Exposure to petrol fumes was found to have several negative impacts on the health of petrol station attendants. A study analyzed the blood and urine of attendants with varying exposure durations (0 to 4 years). Key findings include:
1) Haematological analysis showed significantly lower red blood cell counts and haemoglobin levels in exposed groups compared to unexposed controls, indicating the development of anaemia.
2) White blood cell counts also decreased with increased exposure, suggesting possible immune system suppression.
3) Urine analysis found elevated levels of nitrites, bilirubin, and urobilinogen in the most exposed group, indicating potential urinary tract infections and liver problems.
4)
RP-HPLC Method Developed for the Estimation of Etodolac and Thiocolchicoside ...ijtsrd
A new, simple, specific, sensitive, rapid, accurate and precise RP HPLC method was developed for the estimation of Etodolac ETO and Thiocolchicoside THIO in bulk and combined pharmaceutical dosage forms. Etodolac ETO and Thiocolchicoside THIO was chromatographed on a Symmetry ODS C18 4.6mm—250mm, 5µm Column in a mobile phase consisting of Acetonitrile Methanol Acetate Buffer 25 20 55 v v . The mobile phase was pumped at a flow rate of 1.0 ml min with detection at 238 nm. The detector response was linear in the concentration of 200 600µg ml 20 60µg ml for Etodolac and Thiocolchicoside respectively. The intra and inter day variation was found to be less than 2 . The mean recovery of the drug from the solution was 99.98 . The developed method was validated for sensitivity, accuracy, precision, ruggedness and robustness. The RSD results for precision and intermediate precision found less than 2.0 . The LOD and LOQ were found to be 0.86 and 1.18 µg ml for Etodolac and 2.4 and 3.54µg ml for Thiocolchicoside respectively. The proposed method is simple, fast, accurate, precise and reproducible hence it can be applied for routine quality control analysis of Etodolac ETO and Thiocolchicoside THIO in bulk and combined pharmaceutical formulations. Prapulla Putta "RP-HPLC Method Developed for the Estimation of Etodolac and Thiocolchicoside in Bulk and Combined Dosage Forms" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-1 , December 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29703.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/29703/rp-hplc-method-developed-for-the-estimation-of-etodolac-and-thiocolchicoside-in-bulk-and-combined-dosage-forms/prapulla-putta
A simple visible spectrophotometric method is proposed for the determination
of ulipristal acetate present in bulk and tablet formulation. The currently
proposed method is established based on MBTH oxidation by ferric ions to
form an active coupling species (electrophile), followed by its coupling with
the ulipristal in acidic medium to form high intensiϑied green colored chromophore
having max at 609 nm. Validated the method as per the current
guidelines of ICH. Beer’s law was obeyed in the concentration range of 6.25 –
37.50 g mL 1 with a high regression coefϑicient (r > 0.999). Reproducibility,
accuracy, and precision of the method are evident from the low values of R.S.D.
This method can be used in quality control laboratories for routine analysis of
ulipristal acetate in bulk drug and pharmaceutical dosage forms.
Sumit Arora1, Yogesh Tripathi1, Varun Malhotra1*, Kavita Singh1, Shivani Gupta1
1Department of Physiology, Santosh Medical College, Santosh University
*Address for Correspondence: Dr. Varun Malhotra, Professor & HOD, Department of Physiology, Santosh Medical
College, Santosh University, Ghaziabad, India
Received: 19 Sept 2016/Revised: 30 Sept 2016/Accepted: 18 Oct 2016
ABSTRACT- Introduction: Occupational health diseases affect more people every year. The present study is done
evaluate the liver and renal function test in car paint sprayers in Indian settings. Environmental and occupational exposure
to nephrotoxic substance causes impairment of renal and liver functions test.
Material and Methods: Sixty subjects in the age group 18 to 45 year were divided into two groups (each group having
thirty subjects). Group A consisted of healthy controls. Group B consist of healthy, car paint sprayers. Car paint sprayers
had employment duration of 5 to 12 years. Anthropometric and were performed. Statistical analysis was performed using
the Statistical Package for Social Sciences (SPSS-17).
Results: The result of present study suggested that the values of AST, ALT, S. bilirubin and S. albumin were raised in
subjects who were in Group B exposed to organic solvents (used for spraying car painting) when compared with Group A
subjects.
Conclusion: The study confirms the spray pointing is an occupation which involves the risk of liver and renal impairment
and confirms the need of regular examination. The present study results strongly recommend for following appropriate
safety measure while spraying car painting using organic solvents irrespective of their smoking status and age.
Key-words- Renal and Liver function, Car spray painters, BSA, AST, Anthropometry
RP-HPLC Method Developed for the Estimation of Etodolac and Thiocolchicoside ...ijtsrd
A new, simple, specific, sensitive, rapid, accurate and precise RP HPLC method was developed for the estimation of Etodolac ETO and Thiocolchicoside THIO in bulk and combined pharmaceutical dosage forms. Etodolac ETO and Thiocolchicoside THIO was chromatographed on a Symmetry ODS C18 4.6mm—250mm, 5µm Column in a mobile phase consisting of Acetonitrile Methanol Acetate Buffer 25 20 55 v v . The mobile phase was pumped at a flow rate of 1.0 ml min with detection at 238 nm. The detector response was linear in the concentration of 200 600µg ml 20 60µg ml for Etodolac and Thiocolchicoside respectively. The intra and inter day variation was found to be less than 2 . The mean recovery of the drug from the solution was 99.98 . The developed method was validated for sensitivity, accuracy, precision, ruggedness and robustness. The RSD results for precision and intermediate precision found less than 2.0 . The LOD and LOQ were found to be 0.86 and 1.18 µg ml for Etodolac and 2.4 and 3.54µg ml for Thiocolchicoside respectively. The proposed method is simple, fast, accurate, precise and reproducible hence it can be applied for routine quality control analysis of Etodolac ETO and Thiocolchicoside THIO in bulk and combined pharmaceutical formulations. Prapulla Putta "RP-HPLC Method Developed for the Estimation of Etodolac and Thiocolchicoside in Bulk and Combined Dosage Forms" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-1 , December 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29703.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/29703/rp-hplc-method-developed-for-the-estimation-of-etodolac-and-thiocolchicoside-in-bulk-and-combined-dosage-forms/prapulla-putta
A simple visible spectrophotometric method is proposed for the determination
of ulipristal acetate present in bulk and tablet formulation. The currently
proposed method is established based on MBTH oxidation by ferric ions to
form an active coupling species (electrophile), followed by its coupling with
the ulipristal in acidic medium to form high intensiϑied green colored chromophore
having max at 609 nm. Validated the method as per the current
guidelines of ICH. Beer’s law was obeyed in the concentration range of 6.25 –
37.50 g mL 1 with a high regression coefϑicient (r > 0.999). Reproducibility,
accuracy, and precision of the method are evident from the low values of R.S.D.
This method can be used in quality control laboratories for routine analysis of
ulipristal acetate in bulk drug and pharmaceutical dosage forms.
Sumit Arora1, Yogesh Tripathi1, Varun Malhotra1*, Kavita Singh1, Shivani Gupta1
1Department of Physiology, Santosh Medical College, Santosh University
*Address for Correspondence: Dr. Varun Malhotra, Professor & HOD, Department of Physiology, Santosh Medical
College, Santosh University, Ghaziabad, India
Received: 19 Sept 2016/Revised: 30 Sept 2016/Accepted: 18 Oct 2016
ABSTRACT- Introduction: Occupational health diseases affect more people every year. The present study is done
evaluate the liver and renal function test in car paint sprayers in Indian settings. Environmental and occupational exposure
to nephrotoxic substance causes impairment of renal and liver functions test.
Material and Methods: Sixty subjects in the age group 18 to 45 year were divided into two groups (each group having
thirty subjects). Group A consisted of healthy controls. Group B consist of healthy, car paint sprayers. Car paint sprayers
had employment duration of 5 to 12 years. Anthropometric and were performed. Statistical analysis was performed using
the Statistical Package for Social Sciences (SPSS-17).
Results: The result of present study suggested that the values of AST, ALT, S. bilirubin and S. albumin were raised in
subjects who were in Group B exposed to organic solvents (used for spraying car painting) when compared with Group A
subjects.
Conclusion: The study confirms the spray pointing is an occupation which involves the risk of liver and renal impairment
and confirms the need of regular examination. The present study results strongly recommend for following appropriate
safety measure while spraying car painting using organic solvents irrespective of their smoking status and age.
Key-words- Renal and Liver function, Car spray painters, BSA, AST, Anthropometry
Development and validation of hplc method for determination of theophylline a...IJSIT Editor
A stable, simple, rapid, precise, accurate HPLC method for analysis of Theophyllinee and 1-Methyl
Uric Acid was developed and validated as per ICH guidelines without need of any internal standard.
Separation was carried out using X’terra RP18 (250*4.6) mm, 5µ column with potassium dihydrogen
orthophosphate buffer (pH 3): acetonitrile (30:70 v/v) as mobile phase with flow rate 1 mL min-1. The
parameters studied were retention time, linearity and range, accuracy, precision. The proposed method can
be used for determination of Theophylline and 1-Methyl Uric Acid from Human plasma.
Supercritical fluid (CO2) chromatography for quantitative determination of se...Ratnakaram Venkata Nadh
In the present study, two cancer therapeutic drugs (docetaxel and bortezomib) were separated from their
potential impurities on a chromatographic platform by utilizing CO2 gas (supercritical state) and quantified.
The chromatographic separations were achieved on two short columns BEH-2EP (100mm 3mm, 1.7 mm)
and CHIRALPAK AD-3 (100 mm 4.6 mm, 3 mm) for docetaxel and bortezomib, respectively. The present
work describes the role of organic modifiers in the separation of polar compounds by supercritical fluid
chromatography. The two new methods were fully validated in accordance with the current ICH
(International Council for Harmonization of technical requirements for pharmaceuticals for human use)
guidelines. The stability indicating power of the methods was demonstrated from the stress studies
conducted on the injection formulations of the two compounds. The methods are precise with % RSD of
0.4, linear with the correlation coefficient of r2 $ 0.999 and accurate in the range of 50–150% of the
target assay concentration. The two methods can be equally employed for the assay determination of
docetaxel and bortezomib APIs as well.
The drug or drug combination may not be official in any pharmacopoeias.
A proper analytical procedure for the drug may not be available in the literature due to patent regulations.
Analytical methods may not be available for the drug in the form of a formulation due to the interference caused by the formulation excipients.
Analytical methods for the quantitation of the drug in biological fluids may not be available.
Analytical methods for a drug in combination with other drugs may not be available.
The existing analytical procedures may require expensive reagents and solvents. It may also involve cumbersome extraction and separation procedures and these may not be reliable.
Stability Indicating RP HPLC Method Development and Validation of Everolimus ...ijtsrd
Everolimus is semisynthetic derivative of sirolimus, which is isolated from Streptomyces hygroscopicus. A novel reversed phase high performnce liquid chromatography HPLC method for determination of the everolimus in the presence of degradation product or pharmaceutical excipients. Seperation was carried out using Cosmosil C18 250mm x 4. 6ID , column having particle size 5 micron using acetonitrile and methanol mixture, and pH adjusted to 3, a flow rate of 1. 0 mL min, and ultraviolet detection at 285nm. A retention time nearly 3. 806 min was observed. The calibration curve for everolimus was linear from range of 5 25 µg mL with limit of detection and limit of quantitation of 0. 0817 and 0. 2478 µg mL, respectively. Analytical validation parameters such as selectivity, specificity, linearity, accuracy and precision were evaluated and relative standard deviation value for all the key parameters were less than 2. 0 . The stability indicating method was developed by exposing the drug to stress conditions of acid and base hydrolysis, oxidation, photodegradation, and thermal degradation the obtained degraded products were successfully seperated from the APIs. This method was validated in acceptance with ICH guidelines and results within the acceptance criteria. Rushikesh Mulay | Rishikesh Bachhav "Stability Indicating RP-HPLC Method Development and Validation of Everolimus in Bulk and Pharmaceutical Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46341.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46341/stability-indicating-rphplc-method-development-and-validation-of-everolimus-in-bulk-and-pharmaceutical-dosage-form/rushikesh-mulay
Analytical Method Development and Validation of Metformin Hydrochloride by us...ijtsrd
A simple and reproducible method was developed for Metformin MET by Reverse Phase High Performance Liquid Chromatography RP HPLC . Metformin was separated on C18 column 4.6x250mm, particle size 5µm , using combination of phosphate buffer with pH of 3.0 and Methanol at the UV detection of 238nm. Isocratic elution of phosphate buffer with pH of 3.0 and Methanol was used as a mobile phase with various ratios and flow rates, eventually 30 70 v v phosphate buffer with pH of 3.0 and Methanol was being set with the flow rate of 1mL min. The statistical validation parameters such as linearity, accuracy, precision, inter day and intra day variation were checked, assay studies of Metformin were within 98 to 102 indicating that the proposed method can be adoptable for quality control analysis of Metformin. Mr. Nilesh Nikam | Dr. Avish Maru | Dr. Anil Jadhav | Dr. Prashant Malpure ""Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-3 , April 2019, URL: https://www.ijtsrd.com/papers/ijtsrd22812.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/22812/analytical-method-development-and-validation-of-metformin-hydrochloride-by-using-rp-hplc-with-ich-guidelines/mr-nilesh-nikam
Monitoring histological changes in oral mucosa using AgNORs as biomarkers for...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Haemolysis effect of Mefenamic Acid 250 mg Capsule in Bio analysis by liquid ...IOSR Journals
A rapid, simple and specific method for estimation of Mefenamic acid in human plasma was validated using Indomethacin as internal standard. The analyte and internal standard were extracted from plasma using simple solid phase extraction. The compound were separated on a reverse-phase column with an isocratic mobile phase consisting of 2 mM Ammonium Acetate in Water and acetonitrile (20:80, v/v) and detected by tandem mass spectrometry in negative ion mode. The ion transition recorded in multiple reaction monitoring mode were m/z 240.1 196.0 for Mefenamic acid and m/z 356.1312.0 for internal standard. Linearity in plasma was observed over the concentration range 35.000 – 7000.000 ng/mL for Mefenamic acid. The cv of the assay was 4.89 % to 5.98 % and accuracy was 99.36 to 102.20 % Intra and Interday respectively at LLOQ level. The validated method was applied to bioequivalence study of 250 mg Mefenamic acid in 28 healthy human volunteers. Total 50 samples from individual volunteers identified as Haemolyzed which were analyze initial and repeat again to cross check the method reproducibity for Haeamolysis effect and compared which found acceptable range
Bioequivalence Study of the Two Products of Efavirenz by Validated Analytical...BRNSS Publication Hub
The aim of this study was to find whether the bioavailability of a 600 mg efavirenz capsule (E.F.600 capsule, test) produced by Macneil and Argus Pharmaceutical Ltd. was equivalent to the tablet EFAVIR produced by the Cipla Ltd. (reference preparation). The pharmacokinetic parameters assessed in this study were area under the plasma –concentration time curve 0–96 h (AUCt), area under the plasma concentration time curve from time 0 to ∞ (AUCinf), the peak plasma concentration of drug (Cmax), time needed to achieve the peak plasma concentration (tmax), and the elimination half-life (t½). This was a randomized, single-blind, two-period, crossover study which included 20 healthy adult male and female subjects under fasting conditions. In each of the two study periods (separated by a washout of 1 week), single dose of test or reference drug was administered. Blood samples were taken up to 96 h past dose, the plasma was separated, and the concentrations of efavirenz were determined by high-performance liquid chromatography -UV method. Bioavailability and bioequivalence studies play a key role during the phase of drug development for both innovator drugs and generic drugs and thus have gained a great attention over the past few decades. Bioequivalence study is used to introduce generic drugs of innovator drugs at a lower cost. Hence, a thorough understanding of these bioavailability/bioequivalence studies is required.
Development and validation of hplc method for determination of theophylline a...IJSIT Editor
A stable, simple, rapid, precise, accurate HPLC method for analysis of Theophyllinee and 1-Methyl
Uric Acid was developed and validated as per ICH guidelines without need of any internal standard.
Separation was carried out using X’terra RP18 (250*4.6) mm, 5µ column with potassium dihydrogen
orthophosphate buffer (pH 3): acetonitrile (30:70 v/v) as mobile phase with flow rate 1 mL min-1. The
parameters studied were retention time, linearity and range, accuracy, precision. The proposed method can
be used for determination of Theophylline and 1-Methyl Uric Acid from Human plasma.
Supercritical fluid (CO2) chromatography for quantitative determination of se...Ratnakaram Venkata Nadh
In the present study, two cancer therapeutic drugs (docetaxel and bortezomib) were separated from their
potential impurities on a chromatographic platform by utilizing CO2 gas (supercritical state) and quantified.
The chromatographic separations were achieved on two short columns BEH-2EP (100mm 3mm, 1.7 mm)
and CHIRALPAK AD-3 (100 mm 4.6 mm, 3 mm) for docetaxel and bortezomib, respectively. The present
work describes the role of organic modifiers in the separation of polar compounds by supercritical fluid
chromatography. The two new methods were fully validated in accordance with the current ICH
(International Council for Harmonization of technical requirements for pharmaceuticals for human use)
guidelines. The stability indicating power of the methods was demonstrated from the stress studies
conducted on the injection formulations of the two compounds. The methods are precise with % RSD of
0.4, linear with the correlation coefficient of r2 $ 0.999 and accurate in the range of 50–150% of the
target assay concentration. The two methods can be equally employed for the assay determination of
docetaxel and bortezomib APIs as well.
The drug or drug combination may not be official in any pharmacopoeias.
A proper analytical procedure for the drug may not be available in the literature due to patent regulations.
Analytical methods may not be available for the drug in the form of a formulation due to the interference caused by the formulation excipients.
Analytical methods for the quantitation of the drug in biological fluids may not be available.
Analytical methods for a drug in combination with other drugs may not be available.
The existing analytical procedures may require expensive reagents and solvents. It may also involve cumbersome extraction and separation procedures and these may not be reliable.
Stability Indicating RP HPLC Method Development and Validation of Everolimus ...ijtsrd
Everolimus is semisynthetic derivative of sirolimus, which is isolated from Streptomyces hygroscopicus. A novel reversed phase high performnce liquid chromatography HPLC method for determination of the everolimus in the presence of degradation product or pharmaceutical excipients. Seperation was carried out using Cosmosil C18 250mm x 4. 6ID , column having particle size 5 micron using acetonitrile and methanol mixture, and pH adjusted to 3, a flow rate of 1. 0 mL min, and ultraviolet detection at 285nm. A retention time nearly 3. 806 min was observed. The calibration curve for everolimus was linear from range of 5 25 µg mL with limit of detection and limit of quantitation of 0. 0817 and 0. 2478 µg mL, respectively. Analytical validation parameters such as selectivity, specificity, linearity, accuracy and precision were evaluated and relative standard deviation value for all the key parameters were less than 2. 0 . The stability indicating method was developed by exposing the drug to stress conditions of acid and base hydrolysis, oxidation, photodegradation, and thermal degradation the obtained degraded products were successfully seperated from the APIs. This method was validated in acceptance with ICH guidelines and results within the acceptance criteria. Rushikesh Mulay | Rishikesh Bachhav "Stability Indicating RP-HPLC Method Development and Validation of Everolimus in Bulk and Pharmaceutical Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46341.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46341/stability-indicating-rphplc-method-development-and-validation-of-everolimus-in-bulk-and-pharmaceutical-dosage-form/rushikesh-mulay
Analytical Method Development and Validation of Metformin Hydrochloride by us...ijtsrd
A simple and reproducible method was developed for Metformin MET by Reverse Phase High Performance Liquid Chromatography RP HPLC . Metformin was separated on C18 column 4.6x250mm, particle size 5µm , using combination of phosphate buffer with pH of 3.0 and Methanol at the UV detection of 238nm. Isocratic elution of phosphate buffer with pH of 3.0 and Methanol was used as a mobile phase with various ratios and flow rates, eventually 30 70 v v phosphate buffer with pH of 3.0 and Methanol was being set with the flow rate of 1mL min. The statistical validation parameters such as linearity, accuracy, precision, inter day and intra day variation were checked, assay studies of Metformin were within 98 to 102 indicating that the proposed method can be adoptable for quality control analysis of Metformin. Mr. Nilesh Nikam | Dr. Avish Maru | Dr. Anil Jadhav | Dr. Prashant Malpure ""Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-3 , April 2019, URL: https://www.ijtsrd.com/papers/ijtsrd22812.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/22812/analytical-method-development-and-validation-of-metformin-hydrochloride-by-using-rp-hplc-with-ich-guidelines/mr-nilesh-nikam
Monitoring histological changes in oral mucosa using AgNORs as biomarkers for...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Haemolysis effect of Mefenamic Acid 250 mg Capsule in Bio analysis by liquid ...IOSR Journals
A rapid, simple and specific method for estimation of Mefenamic acid in human plasma was validated using Indomethacin as internal standard. The analyte and internal standard were extracted from plasma using simple solid phase extraction. The compound were separated on a reverse-phase column with an isocratic mobile phase consisting of 2 mM Ammonium Acetate in Water and acetonitrile (20:80, v/v) and detected by tandem mass spectrometry in negative ion mode. The ion transition recorded in multiple reaction monitoring mode were m/z 240.1 196.0 for Mefenamic acid and m/z 356.1312.0 for internal standard. Linearity in plasma was observed over the concentration range 35.000 – 7000.000 ng/mL for Mefenamic acid. The cv of the assay was 4.89 % to 5.98 % and accuracy was 99.36 to 102.20 % Intra and Interday respectively at LLOQ level. The validated method was applied to bioequivalence study of 250 mg Mefenamic acid in 28 healthy human volunteers. Total 50 samples from individual volunteers identified as Haemolyzed which were analyze initial and repeat again to cross check the method reproducibity for Haeamolysis effect and compared which found acceptable range
Bioequivalence Study of the Two Products of Efavirenz by Validated Analytical...BRNSS Publication Hub
The aim of this study was to find whether the bioavailability of a 600 mg efavirenz capsule (E.F.600 capsule, test) produced by Macneil and Argus Pharmaceutical Ltd. was equivalent to the tablet EFAVIR produced by the Cipla Ltd. (reference preparation). The pharmacokinetic parameters assessed in this study were area under the plasma –concentration time curve 0–96 h (AUCt), area under the plasma concentration time curve from time 0 to ∞ (AUCinf), the peak plasma concentration of drug (Cmax), time needed to achieve the peak plasma concentration (tmax), and the elimination half-life (t½). This was a randomized, single-blind, two-period, crossover study which included 20 healthy adult male and female subjects under fasting conditions. In each of the two study periods (separated by a washout of 1 week), single dose of test or reference drug was administered. Blood samples were taken up to 96 h past dose, the plasma was separated, and the concentrations of efavirenz were determined by high-performance liquid chromatography -UV method. Bioavailability and bioequivalence studies play a key role during the phase of drug development for both innovator drugs and generic drugs and thus have gained a great attention over the past few decades. Bioequivalence study is used to introduce generic drugs of innovator drugs at a lower cost. Hence, a thorough understanding of these bioavailability/bioequivalence studies is required.
Introduction: Carbon Monoxide (CO) is a colourless, odourless and euphoric gas produced as a result of incomplete combustion of organic materials. It could either cause morbidity or mortality depending on the concentration and duration of exposure. Aim: The aim of this study was to examine the long term effect of CO inhalation on haematological parameters.
Cytogenetic, Hematological and Enzymes Levels Parameters in the Biomonitoring...inventionjournals
Studies have demonstrated genotoxic effects by the presence of micronucleus in exfoliated cells from the buccal mucosa of agricultural workers exposed to pesticides. This study has assessed the genotoxic effects of pesticides on 61 agricultural workers from the state of Piauí, Brazil. 31 individuals were exposed to pesticides and 30 are from the same area, but were not involved in pesticides application. Cytogenetic damage were evaluated through micronucleus test in cells from the buccal mucosa and some parameters such as hematological and levels of enzymes. Exposed individuals exhibited cytogenetic damage with increased number of micronuclei in cells from the buccal mucosa in comparison with subjects from the control group with significant statistical difference (P < 0.01). We perceive that there is a statistically no significant (P > 0.05) increase in levels of plasmatic and eritrocytaireacetylcholinesterase and no statistically significant increase of phosphatase alkaline were detected in exposed workers in relation to the control group. No association was found in relation to smoking habits, alcohol consumption, protection utensils and the biomarkers analyzed or the biochemical analysis. Analysis of variance revealed a correlation between occupational exposure to pesticides of workers in Piauí and the presence of micronuclei (P < 0.05).
Cytogenetic, Hematological and Enzymes Levels Parameters in the Biomonitoring...inventionjournals
Studies have demonstrated genotoxic effects by the presence of micronucleus in exfoliated cells from the buccal mucosa of agricultural workers exposed to pesticides. This study has assessed the genotoxic effects of pesticides on 61 agricultural workers from the state of Piauí, Brazil. 31 individuals were exposed to pesticides and 30 are from the same area, but were not involved in pesticides application. Cytogenetic damage were evaluated through micronucleus test in cells from the buccal mucosa and some parameters such as hematological and levels of enzymes. Exposed individuals exhibited cytogenetic damage with increased number of micronuclei in cells from the buccal mucosa in comparison with subjects from the control group with significant statistical difference (P < 0.01). We perceive that there is a statistically no significant (P > 0.05) increase in levels of plasmatic and eritrocytaireacetylcholinesterase and no statistically significant increase of phosphatase alkaline were detected in exposed workers in relation to the control group. No association was found in relation to smoking habits, alcohol consumption, protection utensils and the biomarkers analyzed or the biochemical analysis. Analysis of variance revealed a correlation between occupational exposure to pesticides of workers in Piauí and the presence of micronuclei (P < 0.05).
Cytogenetic, Hematological and Enzymes Levels Parameters in the Biomonitoring...inventionjournals
Studies have demonstrated genotoxic effects by the presence of micronucleus in exfoliated cells from the buccal mucosa of agricultural workers exposed to pesticides. This study has assessed the genotoxic effects of pesticides on 61 agricultural workers from the state of Piauí, Brazil. 31 individuals were exposed to pesticides and 30 are from the same area, but were not involved in pesticides application. Cytogenetic damage were evaluated through micronucleus test in cells from the buccal mucosa and some parameters such as hematological and levels of enzymes. Exposed individuals exhibited cytogenetic damage with increased number of micronuclei in cells from the buccal mucosa in comparison with subjects from the control group with significant statistical difference (P < 0.01). We perceive that there is a statistically no significant (P > 0.05) increase in levels of plasmatic and eritrocytaireacetylcholinesterase and no statistically significant increase of phosphatase alkaline were detected in exposed workers in relation to the control group. No association was found in relation to smoking habits, alcohol consumption, protection utensils and the biomarkers analyzed or the biochemical analysis. Analysis of variance revealed a correlation between occupational exposure to pesticides of workers in Piauí and the presence of micronuclei (P < 0.05).
12 weeks Switch to Vaping: Science of Vaping Fontem Ventures
A randomised, parallel group clinical study was performed to evaluate the safety profile of an e-vapour
product (EVP; 2.0% nicotine) in smokers of conventional cigarettes (CCs) switching to use the EVP for 12
weeks.
QIVIVE extrapolation requires a precise correlation between exposure and the effective chemical concentration at the site where the MIE occurs.
This work demonstrates that intracellular distribution is not ruled only by physical-chemical parameters, rather it is mainly regulated by specific biological-mediated mechanisms. Substances with
apparent chemical similarity may show different distribution profile, as shown by the intra-nuclear distribution of polyphenols. While our results derive from a limited number of substances applied to
one cell line, it is plausible that using different substances and/or different cell lines would also have shown that intracellular distribution is not directly related to physical-chemical parameters.
Chemical uptake should be specifically measured and simple extrapolations based on physical-chemical properties may provide misleading decision
1. European International Journal of Science and Technology Vol. 4 No. 3 March, 2015
1
Comparative Haematology and Urinary Analysis of Passive
Inhalers of Petrol Fumes (Petrol Station Attendants) in
Benin City, Nigeria
1
Prosper Opute, 2
Bigila Christian Oghortaire, 3
Erhunmwunse Nosakhare Osazee,
4
Prekeyi Tawari-Fufeyin,
1-4
Department of Animal and Environmental
Biology, Faculty of Life Sciences, University of Benin,
Benin City, Nigeria
Authors Email: ashibudike.opute@uniben.edu1
, faithworld4@gmail.com2
,
nosakhare.erhunmwunse@uniben.edu3
, prekeyi@uniben.edu4
1
Corresponding Author
ABSTRACT
The study investigated the effects of exposure to petrol fumes on haematological parameters and urine
composition of petrol station attendants in Benin City, Edo state, Nigeria. 2ml venous blood and 5ml voided
urine samples were collected from volunteer petrol station attendants and subjected to haematological and
urine composition analysis. Results of haematological analysis indicated significant changes in
haemoglobin concentration, packed cell volume, red blood cell and white blood cell counts (p>0.05). Urine
composition analysis indicated high levels of bilirubin, urobilinogen and nitrites in the voided urine of
exposed subjects. Urine analysis also revealed complete absence of ketone, glucose and leucocytes in the
urine of all exposure groups. Degree of these changes was observed to depend on exposure duration.
Findings from this study indicates that exposure to petrol fumes has haemotoxic implications with high
possibility of inducing anaemia evidenced by significant reductions in red blood cell count as well as
possible immune depressing effects, indicated by significant reduction in white blood cell count and the
presence of nitrites in the voided urine of exposed individuals.
Keywords: Haematology, Petrol fumes, Petrol station attendants, Urine composition, Passive inhalers,
Haemotoxic.
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1. INTRODUCTION
Petrol is one of the largest volume commercial products in the world and is largely a mixture of
normal and branched-chain aliphatic hydrocarbons with boiling points of 39-204o
C, and composition that
depends on the source of raw material (crude oil), the refining processes, performance specifications, season
and other factors (Gabriel et al., 2007). According to WHO (2011), acute poisoning with petrol usually
arises from inhalation of vapour as a result of industrial accident or deliberate abuse (sniffing or ingestion)
and many of the effects of exposure to petrol include headache, dizziness, nausea, vomiting, confusion,
tremor, disorientation, coma and cardiac arrhythmias.
Petrol station attendants (PSAs) are individuals (male or female) responsible for dispensing petroleum
products such as Premium Motor Spirit (PMS) at automobile re-fueling stations. In Nigeria, most PSAs
dispense fuel into vehicles without using any protective device to minimize their exposure to fumes.
Therefore, automobile re-fueling stations are reasonable sources of exposure to petrol vapours among PSAs
in Nigeria. This raises serious public health concern since this class of workers is usually not provided with
regular medical check-ups to detect potential risk of exposure to the fumes.
The toxicity of gasoline, benzene, toluene and xylene has been investigated in both short and long
term exposures. Human studies have often involved acute environmental (accidental and deliberate
inhalation) and chronic occupational exposure to gasoline or to a mixture of gasoline components
(particularly the aromatic components) while studies using laboratory animals have often focused on
subacute and subchronic effects from exposure to gasoline and its major constituents (Uboh et al., 2009).
With this in view, this study was designed to investigate the effects of exposure to petrol fumes on
haematology and urine composition of apparently healthy but consistent human passive inhalers of the
fumes using volunteer petrol station attendants in Benin City, Nigeria.
2. MATERIALS AND METHODS
2.1. Ethical Consideration
Experimental protocols and procedures used in this study conform to the position statement and
guidelines regarding toxicological studies by Ethics and research committee of the University of Benin,
Benin City, Nigeria. Approval was given by the committee before the commencement of the research work
with number AEB/UBREPC/059.
This study was carried out for a period of one week on adult human subjects aged between 18 to 25
years who gave informed consent to the study. Five fuel stations located in Benin City metropolis were used
as sites for this study. A total of twenty five subjects took part in this study, consisting of five groups of five
individuals each. Grouping was done on the basis of exposure duration in years (0, 1, 2, 3 and 4 years).
Group 0 served as the control which is made up of students of the University of Benin who have never
worked as fuel station attendants. The PSAs work on the average of 8 hours per day and approximately 50
hours per week. The basis of comparison between the experimental and control group was age and not
educational status.
2.2. Collection Of Blood Samples
Venous blood (2ml) was taken from a peripheral vein on the arm of each subject using sterile syringes and
immediately transferred into sterile bottles containing potassium EDTA anticoagulant for the haematogical
analysis. The blood samples obtained were kept in wet ice prior to haematogical analysis.
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2.3. Collection Of Urine Samples
Voided urine samples (5ml) were obtained from willing subjects using sterile urine sample bottles and
immediately transferred to the urinalysis laboratory of the University of Benin teaching Hospital for
assessment of urine composition.
2.4. Haematological Analysis
The whole blood samples were analyzed using KX-21N automated machine (Sysmex Corporation, Kobe-
Japan) following the manufacturer’s instructions. Each sample was mixed briefly and placed in contact with
the sample probe for aspiration. The unit executed automatic analysis, and the result was displayed on the
LCD screen. Haematological parameters analyzed for included: haemoglobin concentration (Hb), packed
cell volume (PCV), total red blood cell (RBC) and white cell (WBC) counts, mean corpuscular
haemoglobin, (MCH), mean corpuscular haemoglobin concentration (MCHC) and mean corpuscular volume
(MCV).
2.5. Anaysis Of Urine Composition
Analysis of urine composition was done using urinalysis strips (Medi-Test Combi 10 SGL Urine Test Strips
~ Medisave, UK). The strips were dipped in 5ml of voided urine and removed within 60 seconds. Colour
developed on the strip was compared with a urinalysis chat indicating semi-quantitative measurements of
urine composition.
2.6. Statistical Analysis
This was carried out using student’s t-test and ANOVA to compare the mean values of the test groups with
the control. P > 0.05 was considered to be statistically significant.
3. RESULTS
3.1. HAEMATOLOGICAL ANALYSIS
3.1.1. Haemoglobin Concentration (g/dl)
Mean haemoglobin concentration ranged from 8.35 ± 0.12 g/dl to 12.56 ± 0.01 g/dl in the exposure groups.
The mean values were significantly lower than the control value (14.69 ± 0.01) at p < 0.05 as shown in table
1.
3.1.2. Packed Cell Volume (%)
Mean values of packed cell volume in the exposure groups ranged from 35.08 ± 0.35% to 38.69 ± 0.06 %
and showed a progressive decrease with increase in exposure duration and vary significantly from the
control value (42.63 ± 0.31) at p < 0.05, table 1.
3.1.3. Red Blood Cell (RBC) Count (cells/mm3
)
Red blood cell count showed a general decrease with increase in exposure duration. When compared with
the control group, mean values of red blood cell count in individuals in all exposure groups were
significantly different from the control (table 1).
3.1.4. White Blood Cell (WBC) Count (cells/mm3
)
Mean values of white blood cell count showed a progressive decrease in all exposures groups when
compared with the control group and ranged from 3.01±0.14 cells/mm3
to 3.51±0.01 cells/mm3
(table 1).
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3.1.5. Mean Corpuscular Volume (MCV) (fl)
Mean values of MCV ranged from 90.14 ± 0.60-96.00 ± 1.59fl in exposure groups and showed a general
decrease in comparison with the control group (97.17± 0.12fl). MCV in individuals with 3 and 4 years
exposure duration were significantly different (p < 0.05) from the control group (table 1).
3.1.6. Mean Corpuscular Haemoglobin Concentration (MCHC) (%) and Mean Corpuscular
Haemoglobin (MCH) (pg)
Values of mean corpuscular haemoglobin concentration recorded in the exposure groups showed a general
increase with increasing exposure duration (table 1) but were lower compared to the control.
With the exception of individuals with four years of exposure duration, mean values of MCH were not
significant (p ˃ 0.05) when compared with the control value (table 1).
3.2.Urine Composition Analysis
Results of urine composition analysis indicated high presence of nitrites, haemoglobin, bilirubin and
urobilinogen in the voided urine of subjects in the four years exposure groups (table 2).
4. DISCUSSION
4.1. HAEMATOLOGICAL ANALYSIS
4.1.1. Haemoglobin Concentration (g/dl)
Mean haemoglobin concentration ranged from 8.35 ± 0.12 g/dl to 12.56 ± 0.01 g/dl in the exposure groups.
The mean values were significantly lower than the control value (14.69 ± 0.01) at p < 0.05 as shown in table
1. Haemoglobin is the iron-containing oxygen transport metalloprotein in red blood cells. According to
Eachempati (2007), this decrease with or without absolute reduction in red blood cells is characteristic of
anaemia. This finding agrees with the report that exposure to toxic component of petroleum can alter blood
chemistry and induce bone marrow hypoplasia in animals resulting to anaemia (Marieb, 1995).
4.1.2. Packed Cell Volume (%)
Mean values of packed cell volume in the exposure groups ranged from 35.08 ± 0.35% to 38.69 ± 0.06 %
and showed a progressive decrease with increase in exposure duration and vary significantly from the
control value (42.63 ± 0.31) at p < 0.05, table 1. Increase haemolysis from exposure to toxicants and other
exogenous agents lowers the number of red blood cells per cubic millimeter of blood (Hillman et al., 2005)
and may explain the significant reduction in packed cell volume observed in this study.
4.1.3. Red Blood Cell (RBC) Count (cells/mm3
)
Red blood cell count showed a general decrease with increase in exposure duration. When compared with
the control group, mean values of red blood cell count in individuals in all exposure groups were
significantly different from the control (table 1). Reductions in the red blood cell count observed may not be
unrelated to excessive haemolysis and inhibition of haematopoesis in subjects due to exposure to toxic
components of petrol fumes. Toxicant administration has been implicated in haemolytic anaemia
characterized by reduced bone marrow red blood cell production (Okoro et al., 2006).
4.1.4. White Blood Cell (WBC) Count (cells/mm3
)
Mean values of white blood cell count showed a progressive decrease in all exposures groups when
compared with the control group and ranged from 3.01±0.14 cells/mm3
to 3.51±0.01 cells/mm3
(table 1).
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White blood cells function primarily in body defense against foreign bodies and this is often achieved
through leucocytosis and antibody production (Marieb, 1995 and Okoro et al., 2006). Results of the study
indicated that white blood cell count decreased significantly in all exposure groups. This observation points
to the possibility that exposure to petrol fume may have a compromising effect on humoral immune
responses and phagocytic cell migration necessary for the defense of the body against viruses, bacteria and
other exogenous substances. Similar observation, including pancytopaenia and total bone marrow aplasia
has been attributed to exposure to benzene (d’Azevedo et al., 1996) and leukocytopaenia due to exposure to
xylene (d’Azevedo et al., 1996) both of which are important components of petrol fumes.
4.1.5. Mean Corpuscular Volume (MCV) (fl)
Mean values of MCV ranged from 90.14 ± 0.60-96.00 ± 1.59fl in exposure groups and showed a general
decrease in comparison with the control group (97.17± 0.12fl). MCV in individuals with 3 and 4 years
exposure duration were significantly different (p < 0.05) from the control group (table 1). Mean corpuscular
volume measures the red blood cell average as a part of a standard complete blood count and gives an
indication of the size of red blood cells. Low MCV recorded in all exposure groups is indicative of
microcytic anaemia which may be attributed to the haemotoxic effects of petrol fume exposure.
4.1.6. Mean Corpuscular Haemoglobin Concentration (MCHC) (%) and Mean Corpuscular
Haemoglobin (MCH) (pg)
Values of mean corpuscular haemoglobin concentration recorded in the exposure groups showed a general
increase with increasing exposure duration (table 1) but were lower compared to the control.
With the exception of individuals with four years of exposure duration, mean values of MCH were not
significant (p ˃ 0.05) when compared with the control value (table 1). Mean corpuscular haemoglobin
(MCH) and mean corpuscular haemoglobin concentration (MCHC) both indicates the haemoglobin content
per red blood cell in a sample of blood and aid in the diagnosis of anaemia (Zuckerman, 2007). These
observations further confirm the haemotoxic effect of petrol fume exposures.
4.2. Urine Composition Analysis
Results of urine composition analysis indicated high presence of nitrites in the voided urine of subjects in
the four years exposure groups (table 2). Normally the urinary tract and urine are free of bacteria.
When bacteria find their way into the urinary tract, they can cause a urinary tract infection (UTI). A positive
nitrite test result can indicate a UTI (Gallagher et al., 1990). This observation which is indicative of possible
bacterial infections in these individuals further confirms the immune depressing effect of petrol fume
exposure in these subjects. Hemoglobin was also present in the urine of subjects in the four years exposure
group (table 2). Hemoglobin is an oxygen-transporting protein found inside red blood cells (RBCs). Its
presence in the urine indicates blood in the urine (known as hematuria). The small number of RBCs
normally present in urine usually results in a "negative" test. However, when the number of RBCs increases,
they are detected as a "positive" test result. Even small increases in the amount of RBCs in urine can be
significant. Numerous diseases of the kidney and urinary tract, as well as trauma, medications, smoking, or
strenuous exercise can cause hematuria or hemoglobinuria (Grossfeld et al., 2001). The Urine analysis also
indicated the presence of bilirubin as well as urobilinogen (table 2). Bilirubin is not present in the urine of
normal, healthy individuals. Bilirubin is a waste product that is produced by the liver from the hemoglobin
of RBCs that are removed from circulation. It becomes a component of bile, a fluid that is secreted into the
intestines to aid in food digestion. The presence of bilirubin in urine is an early indicator of liver disease and
can occur before clinical symptoms such as jaundice develop. However, Urobilinogen is normally present in
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urine in low concentrations. It is formed in the intestine from bilirubin, and a portion of it is absorbed back
into the bloodstream. Positive test results help detect liver diseases such as hepatitis and cirrhosis and
conditions associated with increased RBC destruction known as hemolytic anemia (Harrison, 2005). The
presence of bilirubin, a breakdown product of haem, as well as urobilinogen in voided samples points to
possible red blood cell breakdown especially in subjects with longer periods of exposure to petrol fumes.
5. Conclusion
The findings of this study provided insight into the effect of petrol fume exposure on some haematological
parameters as well as on urine composition of petrol service station attendants in Benin City Metropolis,
Nigeria who consistently but passively inhale petrol fumes daily during the process of dispensing fuel to
motor vehicles. The findings indicates that exposure to petrol fumes has haemotoxic implications with high
possibility of inducing anaemia evidenced by significant reductions in red blood cell count and presence of
urobilinogen in urine as well as possible immune depressing effects, indicated by significant reduction in
white blood cell count and the presence of nitrites in the voided urine of exposed individuals. Previous
research studies carried out were on composite fumes evaporating from kerosene, petrol and diesel and such
studies were carried out on experimental animals. Hydrocarbons like benzene, metals like lead and volatile
nitrates have all been shown to produce harmful effects on the bone marrow, spleen, and lymph nodes
(Marieb, 1995), Petroleum fumes are therefore environmental pollutants that could have serious
consequences on haematological parameters in exposed humans.
Acknowledgments
The authors are grateful to Professor (Mrs) Tawari-Fufeyin, Dr. (Mrs) Edosonmwan, and Dr (Mrs) Oronsaye
for their technical assistance.
List of Abbreviations
1. Haemoglobin (Hb)
2. Packed Cell Volume (PCV)
3. Red Blood Cell (RBC)
4. White Blood Cell (WBC)
5. Mean Corpuscular Haemoglobin (MCH)
6. Mean Corpuscular Volume (MCV)
7. Mean Corpuscular Haemoglobin Concentration (MCHC)
8. ANOVA: Analysis of Variance
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TABLES
Table 1: Data Summary of Haematological function indices
Exposure Duration Control 1 Year 2 Years 3 Years 4 Years
Parameters (unit)
Hb (g/l) 14.69±0.01 12.56±0.01*
11.10±0.12*
10.19±0.06*
8.35±0.12*
PCV (%) 42.53±0.31 38.69±0.06 38.18±0.35 37.28±0.21*
35.08±0.35*
RBC (cells/mm3
) 4.76±0.01 4.61±0.05 3.30±0.05*
3.15±0.05*
3.05±0.03*
WBC (cells/mm3
) 5.45±0.01 3.51±0.01*
3.23±0.07*
3.13±0.66*
3.01±0.14*
MCH (Pg) 31.27±0.04 30.64±0.03 31.13±0.49 31.03±0.49 29.45±0.14*
MCV (fl) 97.17±0.12 95.00±0.09 96.00±1.59 93.13±1.56*
90.14±0.60*
MCHC (%) 35.53±0.01 30.92±0.01 31.23±0.16 32.53±0.13*
33.80±0.03*
(Values represented as mean ± SE), *=significance (p<0.05)
Table 2: Semi-quantitative urine composition analysis
Exposure
duration
Blood Bilirubin Urobilinogen Ketone Glucose Protein Nitrate Leucocyte pH Specific
gravity
0 Years -ve -ve -ve -ve -ve -ve -ve -ve 6.0 1.010
1 Year -ve -ve -ve -ve -ve -ve -ve -ve 6.0 1.019
2 Years -ve -ve -ve -ve -ve -ve -ve -ve 6.0 1.015
3 Years -ve -ve -ve -ve -ve -ve -ve -ve 6.0 1.021
4 Years +ve +ve +ve -ve -ve -ve +ve -ve 6.0 1.029
(+ve: positive; -ve: negative) Positive signifies presence of a parameter while negative signifies its absence.
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