Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
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ISSN: 2348 –0882

Development And Validation Of First Order Derivative Met...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
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ISSN: 2348 –0882

management of oedema.13-15 HCTZ is
official in IP,BP16,1...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
.

ISSN: 2348 –0882

determination of QUI is carried out by
measuring absorba...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
.

ISSN: 2348 –0882

of standard deviation of the response and the
slope of t...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
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ISSN: 2348 –0882

and Interday (0.25 – 0.43 % and 0.11 – 0.23
%) for QUI a...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
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ISSN: 2348 –0882

Figure 5- Overlain D0 spectra of HCTZ(10-50) µg/ml in me...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
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ISSN: 2348 –0882

Table 3: Precision data for QUI
Concentration
(μg/ml)
12...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
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ISSN: 2348 –0882

Table 8: Accuracy data for QUI and HCTZ
Level

Amount
Am...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
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ISSN: 2348 –0882

the controller & publication, Delhi (volII) :2010,pp:750...
Int. J. Pharm. Res. Sci., 013, 01(1), 16-25.
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ISSN: 2348 –0882

dosage form,” Scholars Research
library,2011,3(5):pp.318...
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Development And Validation Of First Order Derivative Method For Simultaneous Estimation Of Quinapril Hcl And Hydrochlorothiazide In Combined Pharmaceutical Formulation

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A new simple, sensitive, rapid, accurate,
precise and economical Derivative
Spectrophotometric method for the
simultaneous determination of Quinapril
HCl

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Development And Validation Of First Order Derivative Method For Simultaneous Estimation Of Quinapril Hcl And Hydrochlorothiazide In Combined Pharmaceutical Formulation

  1. 1. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 Development And Validation Of First Order Derivative Method For Simultaneous Estimation Of Quinapril Hcl And Hydrochlorothiazide In Combined Pharmaceutical Formulation Reema Jaiswal*1, Pinak patel1 Department of Pharmaceutical Analysis, Indubhai Patel College of Pharmacy and Research Centre, Dharmaj, Gujarat-388430, India 2 Department of Quality Assurance, Indubhai Patel College of Pharmacy and Research Centre, Dharmaj, Gujarat-388430, India 1 ==================================================================== ABSTRACT A new simple, sensitive, rapid, accurate, INTRODUCTION Quinapril Hydrochloride (QUI), a 3precise and economical Derivative Isoquinolinecarboxylic acid,2-[2-[[1Spectrophotometric method for the (ethoxycarbonyl)-3-phenylpropyl]amino]-1simultaneous determination of Quinapril oxopropyl]-1,2,3,4-tetrahydroHCl (QUI) and Hydrochlorothiazide (HCTZ) in their combined pharmaceutical ,monohydrochloride [Figure 1a]. QUI is dosage form was developed. The derivative official in United State Pharmacopoeia Spectrophotometric method was based the (USP) but it is listed in Merck Index 1, absorbance of the solutions were measured Martindale and Complete Drug Reference2-7. at 242.45 nm (λ1), and 257.17 nm (λ2) for It is a ACE inhibitor and indicated in the estimation of both the drugs. The treatment of symptomatic treatment of high linearity was obtained in the concentration blood pressure and used with some other range of 80-240 μg/ml for QUI and 10-50 drugs in combination therapy. Literature μg/ml for HSfl e mean recovery was C survey revealed that various8-12 , Capillary 99.93 – 100.33 % and 99.06-101.25% for electrophoresis, Ion-pair HPLC and HPTLC QUI and HCTZ respectively. The results of methods have been reported for quantitative analysis have been validated statistically as estimation of QUI in pharmaceutical dosage per ICH guidelines. forms and biological fluids individually or in combination with other drugs. KEYWORDS Quinapril Hydrochloride, Hydrochlorothiazide (HCTZ) is chemically Hydrochlorthiazide, Derivative method, 6-Chloro-3,4-dihydro-2H-1,2,4Methanol. benzothiadiazine-7-sulfonamide 1,1-dioxide [Figure 1b]. HCTZ is a thiazide diuretic Corresponding Author inhibits water reabsorption in the nephron by Reema Jaiswal inhibiting the sodium-chloride symporter Email address: jreema42@yahoo.in (SLC12A3) in the distal convoluted tubule, Received: 18.12.2013 which is responsible for 5% of total sodium Revised: 26.12.2013 reabsorption. It is used for the treatment of Accepted: 29.12.2013 the treatment of blood pressure and in 16
  2. 2. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 management of oedema.13-15 HCTZ is official in IP,BP16,17,USP18 and JP19 describe HPLC method for its estimation. The review of literature revealed that various analytical methods involving Spectrophotometry, HPLC20-26and HPTLC 27-29 have been reported for HCTZ in pharmaceutical dosage forms and biological fluids individually or in combination with other drugs. is no published RP-HPLC method for this combination. So, the present paper describes a simple, accurate and precise method for simultaneous estimation of QUI and HCTZ in combined Pharmaceutical Formulation by RP-HPLC method. The eveloped method was validated in accordance with ICH Guidelines30and successfully employed for the assay of QUI and HCTZ in their combined dosage form To the best of our knowledge, there . Figure 1: Chemical structure of (a) QUI and (b) HCTZ An accurately weighed quantity of MATERIALS AND METHODS QUI (100 mg) and HCTZ (100 mg) were Reagents and Chemicals Analytically pure QUI and HCTZ transferred to a separate 100 ml volumetric flask and 50 ml of methanol was added to were kindly provided by Aurobindo Pharmaceuticals Ltd.,Hyderabad and both volumetric flask and sonicated for 5 Chemyes Corporation Vadodara, Gujarat minutes. Volume was adjusted up to the India as gratis samples. Methanol was used mark with methanol to obtain standard as solvent. Tablet of QUI and HCTZ in solution having concentration of QUI (1000 combined dosage form, i.e. Q-PRIL H-10 μg/ml) and HCTZ (1000 μg/ml). 12.5 ml was procured from local market.11-13 solutions of QUI (1000 μg/ml) and 10 ml HCTZ (1000 μg/ml) were transferred to a INSTRUMENTS A Shimadzu UV/Vis 1800 double separate 25 ml volumetric flask and 100 ml beam spectrophotometer with a wavelength volumetric flask respectively and diluted up accuracy (± 0.3 nm), 1 cm matched quartz to concentration of QUI (500 μg/ml) and cells and UV probe 2.32 software was used HCTZ (50μg/ml) with methanol. for all the spectral measurements and First order Derivative method Shimadzu UV/Vis 1601 double beam 80-240 µ g/ml solutions of QUI and 10-50 spectrophotometer with a wavelength µ g/ml solutions of HCTZ were prepared in methanol by appropriate dilution and accuracy (± 0.3 nm) and 1 cm matched spectrum was recorded between 200-400 quartz cells was used for reproducibility nm. The absorbance of the solutions were Study. Calibrated analytical balance K-EA measured at 242.45 nm (λ1), and 257.17 nm 210 (K-Roy Instrument Pvt. Ltd) was used (λ2), for the estimation of both the drugs by for weighing purpose. proposed method. The quantitative Preparation of standard stock solutions 17
  3. 3. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 determination of QUI is carried out by measuring absorbance difference between 242.45 nm and 257.17 nm where HCTZ has same absorbance at both the wavelengths. For estimation of QUI and HCTZ using derivative spectroscopy, zero crossing method was decided to be used. In this method two wavelengths are required. One wavelength is selected at which QUI shows zero absorbance while other drug HCTZ shows considerable absorbance. The second wavelength is selected such that HCTZ shows zero absorbance while QUI shows considerable absorbance. The overlain derivative spectrum (first order) of QUI and HCTZ at different concentrations revealed that at 242.45 nm different concentration of HCTZ possesses zero D1 absorbance whereas QUI possesses significant D1 absorbance. In a similar manner, at 257.17nm different concentrations of QUI possess zero D1 absorbance whereas HCTZ possesses significant D1 absorbance. Considering above facts, wavelength 242.45 nm and 257.17nm were selected for the estimation of QUI and HCTZ respectively Method validation The proposed method has been extensively validated in terms of specificity, linearity, accuracy, precision, limits of detection (LOD) and quantification (LOQ), robustness and reproducibility. The accuracy was expressed in terms of percent recovery of the known amount of the standard drugs added to the known amount of the pharmaceutical dosage forms. The precision (Coefficient of Variation - C.V.) was expressed with respect to the repeatability, intra-day and inter-day variation in the expected drug concentrations. After validation, the developed methods have been applied to pharmaceutical dosage form. Specificity Commonly used excipients (starch, microcrystalline cellulose and magnesium stearate) were spiked into a pre weighed quantity of drugs. The fundamental or normal spectrum was recorded by appropriate dilutions and the quantities of drugs were determined. Linearity Appropriate volume of aliquot from QUI and HCTZ standard stock solution was transferred to volumetric flask of 10 ml capacity. The volume was adjusted to the mark with methanol to give solutions containing 80-240 µ g/ml QUI and 1050µ g/ml HCTZ. All D0 Spectrum were recorded for QUI and HCTZ respectively (n=5). Calibration curves were constructed by plotting average absorbance versus concentrations for both drugs. Straight line equations were obtained from these calibration curves. Accuracy Accuracy was assessed by determination of the recovery of the method by addition of standard drug to the prequantified placebo preparation at 3 different concentration levels 80, 100 and 120 %, taking into consideration percentage purity of added bulk drug samples. Each concentration was analyzed 3 times and average recoveries were measured. Precision The repeatability was evaluated by assaying 6 times of sample solution prepared for assay determination. The intraday and interday precision study of QUI and HCTZ was carried out by estimating different concentrations of QUI (120, 160, 200 µ g/ml) and HCTZ (20, 30, 40 µ g/ml), 3 times on the same day and on 3 different days (second, third, fourth) and the results are reported in terms of C.V. Detection limit and Quantitation limit ICH guideline describes several approaches to determine the detection and quantitation limits. These include visual evaluation, signal-to-noise ratio and the use 18
  4. 4. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 of standard deviation of the response and the slope of the calibration curve. In the present study, the LOD and LOQ were based on the third approach and were calculated according to the 3.3σ/S and 10σ/S criterions, respectively; where σ is the standard deviation of y-intercepts of regression lines and s is the slope of the calibration curve. Robustness The sample solution was prepared and then analyzed with change in the typical analytical conditions like stability of analytical solution. Reproducibility The absorbance readings were measured at different laboratory for sample solution using another spectrophotometer by analyst and the values obtained were evaluated using t- test to verify their reproducibility. Determination of QUI and HCTZ in their Combined Dosage Twenty tablets were weighed and powdered. A powder quantity equivalent to 10 QUI and 12.5 mg HCTZ was accurately weighed and transferred to volumetric flask of 50 ml capacity. 50 ml of methanol was transferred to this volumetric flask and sonicated for 15 min. The flask was shaken and volume was made up to the mark with methanol. The above solution was filtered through whatman filter paper (0.45µ ).The flask was shaken and volume was made up to the mark with methanol. From this solution 4 ml was transferred to volumetric flask of 10 ml capacity. Volume was made up to the mark to give a solution containing 80 µ g/ml of QUI using methanol(Solution A). This solution was used for the estimation of QUI, from (solution A) withdraw 1ml and dilute to 10 ml to give 8 μg/ml QUI and 10 μg/ml HCTZ and solution was used for estimation of HCTZ(solution B). The resulting solution was analyzed by proposed methods. The quantitation was carried out by keeping these values to the straight line equation of calibration curve. RESULTS AND DISCUSSION In First order Derivative wavelength method, For estimation of QUI and HCTZ using derivative spectroscopy, zero crossing method was decided to be used. In this method two wavelengths are required. One wavelength is selected at which QUI shows zero absorbance while other drug HCTZ shows considerable absorbance. The second wavelength is selected such that HCTZ shows zero absorbance while QUI shows considerable absorbance. The overlain derivative spectrum (first order) of QUI and HCTZ at different concentrations revealed that at 242.45 nm different concentration of HCTZ possesses zero D1 absorbance whereas QUI possesses significant D1 absorbance. In a similar manner, at 257.17nm different concentrations of QUI possess zero D1 absorbance whereas HCTZ possesses significant D1 absorbance. Considering above facts, wavelength 242.45 nm and 257.17nm were selected for the estimation of QUI and HCTZ respectively . Calibration data for QUI and HCTZ are shown in Table 2 and 3 respectively. Calibration curves for QUI and HCTZ were plotted between D1 absorbance and concentration. The following equations for straight line were obtained for QUI and HCTZ. Linear equation for QUI, y = 0.002x -0.011 Linear equation for HCTZ, y = 0.030x 0.203 The linearity of the calibration curve was validated by the high values of correlation coefficient of regression. The C.V values for QUI and HCTZ for repeatability was found to be 0.54 and 0.51 %, respectively [Table 1]. The Coefficient of Variance(C.V) (less than 2 %) indicates that the proposed method is repeatable. The C.V values of Intraday (0.52 – 0.89% and 0.10 – 0.48%) 19
  5. 5. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 and Interday (0.25 – 0.43 % and 0.11 – 0.23 %) for QUI and HCTZ, respectively, reveal that the proposed method is precise. LOD values for QUI and HCTZ were found to be 1.88 and 0.18 μg/ml, respectively and LOQ values for QUI and HCTZ were found to be 6.20 and 0.54 μg/ml, respectively [Table 1]. These data show that proposed method is sensitive and precise for the determination of QUI and HCTZ, respectively [Table 3, 4]. The recovery experiment was performed by the standard addition method. The percentage recovery was 99.93 – 100.33% and 99.06 – 101.25% for QUI and HCTZ, respectively [Table 5, 6]. The results of recovery studies indicate that the proposed method is accurate. The proposed validated method was successfully applied to determine QUI and HCTZ in their combined dosage form. The results obtained for QUI and HCTZ was comparable with the corresponding labelled amount. No interference of the excipients with the absorbance of interest appeared; hence the proposed method is applicable for the routine simultaneous estimation of QUI and HCTZ in pharmaceutical dosage forms. Figure 2-Calibration Curve for QUI Figure 3-Calibration Curve for HCTZ Figure 4- Overlain D0 spectra of QUI (80-240)µg/ml in methanol 20
  6. 6. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 Figure 5- Overlain D0 spectra of HCTZ(10-50) µg/ml in methanol Figure 6-QUI& HCTZ- first order ( D1) derivative overlain Table 1: Summary of Validation Parameters of First order Derivative method Parameters QUI HCTZ % Recovery 99.70 – 101.10 99.80 – 101.62 Repeatability(RSD, n=6) 0.54 0.51 Precision(%RSD) Intra-day (n=3) 0.52-0.89 0.10-0.48 Inter-day (n=3) 0.25-0.43 0.11-0.23 LOD 1.88 0.18 LOQ 6.20 0.54 Specificity specific specific Solvent Stability Stable for 24 hours Stable for 24 hours Table 2: Statistical data QUI and HCTZ by First order Derivative method Parameter QUI HCTZ Analytical wavelength 242.45 nm 257.17 nm Range (µ g/ml) 80– 240 10-50 Slope -0.002 0.030 Intercept -0.010 -0.202 Regression Coefficient (r2) 0.997 0.998 Standard deviation of intercept 0.00114 0.00164 21
  7. 7. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 Table 3: Precision data for QUI Concentration (μg/ml) 120 160 200 Intraday C.V. Interday -0.2333±0.0020 0.89 -0.3133±0.0024 0.64 -0.3934±0.0022 0.52 C.V. -0.2321±0.0010 0.43 -0.3120±0.0012 0.30 -0.3921±0.0011 0.25 Table 4: Precision data for HCTZ Concentration Intraday C.V. Interday C.V. (μg/ml) 20 0.4333±0.0020 0.48 0.4320±0.0012 0.23 30 0.6836±0.0025 0.36 0.6820±0.0016 0.14 40 0.9960±0.0010 0.10 0.9981±0.0018 0.10 Table 5 :Reproducibility data for QUI (80 µg/ml) Instrument 1 Mean ± S.D. 0.3153 ± 0.0030 Instrument 2 Mean ± S.D. 0.3166 ± 0.0025 Result of Value from t-distribution t test * table 0.5783 4.30 Inference There is difference no significance no significance Table 6 :Reproducibility data for HCTZ( 10 µg/ml) Instrument 1 Mean ± S.D. 0.2956 ± 0.0025 Instrument 2 Mean ± S.D. 0.2936 ± 0.0015 Result of Value from t-distribution t test * table 4.30 0.4380 Table 7: Specificity and Selectivity study Study QUI Specificity Specific HCTZ Specific Selectivity Selective Selective 22 Inference There is difference
  8. 8. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 Table 8: Accuracy data for QUI and HCTZ Level Amount Amount Std Amount of drug drug added Recovered in present (µg/ml) (µg/ml) % Recovery ± S.D US 80+10 QUI 80 80+10 100 120 HCTZ QUI HCTZ QUI HCTZ 80 16 79.95 15.85 99.93±0.58 99.06± 0.41 80+10 100 20 100.20 20.10 100.20±0.36 100.50±0.52 80+10 120 24 120.40 24.30 100.33±0.47 101.25±0.68 Table 9: Assay Results of Marketed Formulation Tablet Drug Labeled Amount claim taken (mg) (µg/ml) Q-PRIL H-10 QUI 10 80 TAB HCTZ 12.5 10 CONCLUSION The proposed dual wavelength method provides simple, specific, precise, accurate and reproducible quantitative analysis for simultaneous determination of QUI and HCTZ in combined dosage form. The methods were validated as per ICH guidelines in terms of specificity, linearity, accuracy, precision, limits of detection (LOD) and quantification (LOQ), robustness and reproducibility. The proposed methods can be used for routine analysis and quality control assay of QUI and HCTZ in combined dosage form. ACKNOWLEDGEMENT The author is thankful to Indubhai Patel College of Pharmacy and Research Centre (Dharmaj, India) for providing the necessary facilities for research work and to all the staff members and friends for their guidance and help throughout the research work. Amount found (µg/ml) 79.60 9.97 % Label ±S.D claim 98.50±0.0152 99.70±0.0156 REFERENCE: 1. Merk index, fourteenth Edition, page no8048. 2. http://www.pfizer.ca/en/our_products/pr oducts/monograph/183.pp-28-29 [Last Accessed on Oct 2013] 3. K.D.Tripathi. In Essentials of Medical Pharmacology; 6th Edition; Jaypee Brothers Medical Publishers, New Delhi, 2008, pp479-480. 4. http://www.newdruginfo.com/pharmaco poeia/usp28/v28230/usp28nf23s0m7248 .html. 5. United States Pharmacopoeia 30 and National Formulary, (25) Asian Edition, The United States Pharmacopoeia Convention Inc., U.S.A. Volume no 28(6):pp. 2288. 6. http://medlibrary/lib/rx/meds/quinaprilhy drochloride & hydrochlorthiazide3/page2/ 7. Indian pharmacopoeia, Govt. of India “Ministry of health & family welfare” 23
  9. 9. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 the controller & publication, Delhi (volII) :2010,pp:750-751. 8. Merck index, fourteenth Edition, page no-478. 9. http://www.pfizer.ca/en/our_products/pr oducts/monograph/183.pp-31. 10. K.D.Tripathi. In Essentials of Medical Pharmacology; 6th Edition; Jaypee Brothers Medical Publishers, New Delhi, 2008, pp 564-565. 11. http://www.webmed.com/drugs/drug181412&drugname=Accuretic+oral&pa ge number=2. 12. http://www.procanadadrugs.com/generic -q-pril-h-quinapril-hctz-10mg-12-5mg1616.html 13. http://www.medicalnewstoday.com/relea ses/252409.php. 14. United States Pharmacopoeia 30 and National Formulary, (25) Asian Edition, The United States Pharmacopoeia Convention Inc., U.S.A. Volume no 29(4): pp.1068,1069. 15. M. Gandhimati, T. K. Ravi, “Ion-pair HPLC method for the simultaneous estimation of Quinapril HCl and hydrochlorthiazide in tablet”, Indian journal of pharmaceutical science2009. 71(3): pp.311-313. 16. S.Hillaert, K.D.Grauwe, W. Vanden Bossche, “Simultaneous determination of hydrochlorthiazide and several inhibitors of Angiotensin-converting enzymes by capillary electrophoresis,” A journal of chromatography A. 2001. 924(2001):pp-439-449. 17. Girija. B. Bhavsar, V.A.Chatpalliwar, D.D.Patil and S.J.Surana. “Validated HPTLC Method for the simultaneous estimation of Quinapril HCL and hydrochlorthiazide in tablet dosage form.”Indian journal of pharmaceutical science 70(4): pp-529-531. 18. Indian pharmacopoeia, Govt. of India “Ministry of health & family welfare” the controller &publication, Delhi (volII) 2010,page no 570. 19. British Pharmacopoeia, “The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA)”, London, volume–I and II, 2009 Eur. monograph 0394):pp.2982. 20. British Pharmacopoeia, “The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA)”, London, volume–I and II, 2009 Eur. monograph 0394):pp.2982. 21. United States Pharmacopoeia 30 and National Formulary, (25) Asian Edition, The United States Pharmacopoeia Convention Inc., U.S.A. Volume no 28(6): pp.1745 22. S.B.Wankhede, MR.Tajne, K.R.Gupta, S.G.Wadodkar, “RP-HPLC method for simultaneous estimation of telmisartan and hydrochlorthiazide in tablet dosage form,” Indian journal of pharmaceutical science. 2007,69(2):pp.298-300. 23. Khan. M .Rizwan, Shaikh Aris, Thaker A.C, “Simultaneous determination & method Development for assay of Losartan potassium &Hydrochlorthiazide in solid dosage form by RP-HPLC,” Indian journal of pharmaceutical science and research,2(1)2012:pp.42-45 24. Y.Gupta, A.Shrivastava, D.Duggal, A.Patel and S.Agrawal,“A new RPHPLC method for simultaneous estimation of Nebivolol HCl &hydrochlorthiazide in dosage form,” Journal of young Pharmacistyear2009, 1(3):pp.264-269. 25. A.B.N.NageswaraRao, Ojeyemi.M.Olabemicao, V.JayatirthaRao ,J.V.L.N.SeshagirRao , “Development& Validation of RPHPLC method for the simultaneous estimation of Hydrochlorthiazide & Eprosartan in bulk pharmaceutical 24
  10. 10. Int. J. Pharm. Res. Sci., 013, 01(1), 16-25. . ISSN: 2348 –0882 dosage form,” Scholars Research library,2011,3(5):pp.318-325. 26. SB.Wankhede, KC.Raka, SSWadker and SSChitlange,“HPLC methods for simultaneous estimation of amlodipinebesilate, losartan potassium and hydrochlorthiazide in tablet,” Indian journal of pharmaceutical science,72(1): pp.136-140. 27. SurajSahoo, Prassana Kumar, Panda, Sagar Kumar, Mishra,“ HPLC method development for simultaneous estimation of Hydrochlorthiazide and Perindropril in tablet dosage form,”Asian journal of pharmaceutical and Research, 5,2012. 28. N.J.Shah, B.N.Suhagia, R.R.Shah, N.M.Patel, “Development and Validation of a simultaneous HPTLC method for the estimation of Olmesartanmedoxomil& Hydrochlorthiazide in tablet dosage form,” Indian journal of pharmaceutical science, 2007, 69(6):pp.834-836. 29. N.J.Shah, B.N.Suhagia, R.R.Shah, N.M.Patel, “HPTLC method for the simultaneous estimation of Valsartan &Hydrochlorthiazide in tablet dosage form,” Indian journal of pharmaceutical science 2007, 71(1):pp.72-74. 30. Kondawar Manish, Gaikwad Rajdeep, Apate Vishesh ,RavetkarAmit, “HPTLC for the determination of Enalapril maleate &Hydrochlorthiazide in pharmaceutical dosage form,” International journal of pharm tech Research.vol 3(3):pp.1454-1458. 31. RamziaI.El.Bagary, Ehab.F.Elkadu & AbdulgabbbarFaqeh,“Simultaneous determination of Atenolol, Amiloride HCl& Hydrochlorthiazide using RPLiquid chromatography,”Journalof chemical & Pharmaceutical Research2011,3(6):pp.320-329. 32. Japanese Pharmacopoeia, govt of Japan, the ministry of Health , Labour and Welfare 16th edition ,pg:1925. 33. Indian pharmacopoeia, Govt. of India “Ministry of health & family welfare” the controller & publication, Delhi (volII) 2010, 1199-1200 ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2 (R1), International Conference on Harmonization, Geneva, Switzerland No.2005. 25

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