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Development AND VALIDATION OF UV
SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION
OF LISINOPRIL IN BULK AND PHARMACEUTICAL
FORMULATION
SABYA SACHI DAS
PhD Scholar
Dept. Of Pharm. Sci. & Tech.
Birla Institute Of Technology
Mesra,Ranchi-835215,Jharkhand
introduction
 Simple UV-Spectrophotometric methods was
developed for the determination of Lisinopril in
bulk and its pharmaceutical dosage forms.
 Lisinopril exhibited maximum absorption at
241nm by UV spectroscopy using 0.1N NaOH as
the solvent.
 The drug obeys linearity in the concentration
ranges of 5-60 g/ml.
2sabya2049@gmail.com11/30/2017
Drugprofile
LISINOPRIL
Pharmacokinetics data:
Bioavailability: Approximately 25%
Metabolism: Does not undergo metabolism, it is
excreted unchanged entirely in urine.
Half- life: 10-12 hours
Excretion: Renal
3sabya2049@gmail.com11/30/2017
Chemical data:
Empirical formula : C21H31N3O5
Molecular weight : 405.5 gm/mole
Physical stability:
Colour : White to off-white.
Solubility : Soluble in water, sparingly soluble in
methanol, practically insoluble in ethanol.
Melting point : 146-148 ⁰C
Form : Crystalline powder
λ max : 241nm (uv)
4sabya2049@gmail.com11/30/2017
Pharmacological action:
 Lisinopril inhibits angiotensin converting enzyme (ACE) in
human subjects and animals. ACE is a peptidyl dipeptidase
that catalyzes the conversion of angiotensin I to the
vasoconstrictor substance, angiotensin II.
 Angiotensin II also stimulates aldosterone secretion by the
adrenal cortex. The beneficial effects of lisinopril in
hypertension and heart failure appear to result primarily from
suppression of the renin-angiotensin- aldosterone system.
 Inhibition of ACE results in decreased plasma angiotensin II
which leads to decreased vasopressor activity and to
decreased aldosterone secretion.
Category : ACE INHIBITOR (Anti hypertensive drug)
5sabya2049@gmail.com11/30/2017
LITERATUREREVIEWON LISINOPRIL
The Intraday and Interday precision for Lisinopril and its
active metabolite were found to be 0.213±0.0028 and
0.204±0.0019 respectively.
Correlation co-efficient for Lisinopril was found to be 0.9994.
%RSD for lisinopril was found to be 1.314.
HPLC method was validated according to the guidelines of
Food and Drug Administration, showing to be accurate (bias
within ±12%)over the concentration range of 5-60 μg/mL for
Lisinopril.
Absorbance was monitored at 241 nm where Lisinopril has
maximum absorption.
Tablet dosage form was estimated, and percentage recovery
was 98.4-99.87%.
6sabya2049@gmail.com11/30/2017
Parameters Obtained values
Λmax 241nm
Beer’s Law limit (g/ml) 5.60
Sandell’s sensitivity (g/cm2/0.001 AU) 0.0121
Molar Extinction Coefficient (L.mole-1.cm-1) 2.083×10-4
% RSD 1.314
Regression equation (Y)* 0.0096x+0.0192
% Range of error
0.05 confidence limits
0.01 confidence limits
± 0.00156
± 0.01293
Correlation co-efficient 0.9994
OPTICAL CHARACTERISTICS FOR LISINOPRIL:
7sabya2049@gmail.com11/30/2017
LINEARITYTABLEFORLISINOPRILBY UV
SPECTROPHOTOMETRICMETHOD
CONCENTRATION
(µg/ml)
ABSORBANCE
AT 241 nm
5 0.065
10 0.121
20 0.213
30 0.301
40 0.395
50 0.499
60 0.598
8sabya2049@gmail.com11/30/2017
CALIBRATIONCURVEOF LISINOPRILBY UV SPECTROPHOTOMETRICMETHODIN
0.1NNaOHAT 241 nm
0.065
0.121
0.213
0.301
0.395
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
0.45
0 10 20 30 40 50
Aborbance(at241nm)
Concentration(µg/ml)
Calibration curve of Lisinopril by
UV spectrophotometry(Method-I)
9sabya2049@gmail.com11/30/2017
LISINOPRILIN COMMERCIALFORMULATION
FORMUL
-ATION
LABELED
AMOUNT (mg)
OBSERVED
AMOUNT (mg)
±S.D
%
RECOVE-
RY
± S.D.
%R.S.D
PRINIVIL
TABLET
5 mg
4.98
±
0.0122
99.6
±
0.1102
0.1106
10sabya2049@gmail.com11/30/2017
Precision
The precision of the proposed method was
ascertained by actual determination of six
replicates of fixed concentration of the
drug within the Beer’s range and finding
out the absorbance's by the proposed
method.
From these absorbance's Mean, Standard
deviation and %R.S.D was calculated.
11sabya2049@gmail.com11/30/2017
ResultsinPrecision
PRECISION
CONCENTRATI
ON
(µg/ml)
METHOD-I
(MEAN ± SD)
METHOD-II
(MEAN ± SD)
RSD(%)
INTRADAY 20 0.213 ± 0.0028 20.112 ±
0.0121
1.314
INTERDAY 20 0.204 ± 0.0019 20.011 ±
0.0221
0.931
12sabya2049@gmail.com11/30/2017
ACCURACY
 To determine the accuracy of the proposed
method, recovery studies were carried out by
taking different amounts (80%, 100% and 120%)
of bulk samples of Lisinopril within the linearity
range and adding to the pre-analyzed
formulation concentration.
 From that percentage recovery values were
calculated.
13sabya2049@gmail.com11/30/2017
RESULT IN ACCURACY
SAMPLE ID
CONCENTRATION (µg/ml) %RECOVERY OF PURE
DRUG STATISTICAL ANALYSIS
Pure drug Formulation
S1: 80% 8 10 98.45
MEAN= 98.36
SD =0.3286
%RSD = 0.3340
S2: 80% 8 10 98
S3: 80% 8 10 98.64
S4: 100% 10 10 100.12
MEAN= 100.45
SD = 0.6715
%RSD= 0.6684
S5: 100% 10 10 100.23
S6: 100% 10 10 100.02
S7: 120% 12 10 101.23 MEAN= 100.26
SD = 0.864
%RSD= 0.8617
S8: 120% 12 10 99.56
S9: 120% 12 10
100.01
14sabya2049@gmail.com11/30/2017
CONCLUSION
 The proposed method is simple, sensitive and
reliable with good precision and accuracy.
 The proposed method is specific while
estimating the commercial formulations without
interference of excipients and other additives.
 Hence, this method can be used for the routine
determination of Lisinopril in bulk samples and
Pharmaceutical formulations.
15sabya2049@gmail.com11/30/2017
REFERENCE
 GRChatwal, S Anand, Instrumental Methods of Chemical
Analysis; 2002:209-217.
 Scottish intercollegiate guidelines network (sign), control of pain in
adults with cancer-a national clinical guideline. Scotland national
health service (nhs).2008:76-89.
 G. T. Warner and B. Jarvis, Olmesartan medoxomil,
Drugs 62 (2002) 1345–1353.
 Sissmann j, bouroudian m, armagnac c, donazollo y, latreille m, and
panis r. Angiotensin ii blockade in healthy volunteers: tolerability and
impact on renin angiotensin system components of single and
repeated doses of a new angiotensin ii receptor antagonist sr 47436
(bms 186295). J hypertens 1994; 12: s92.
 Metabocard for lisinopril retrieved 29 april 2004: 1010-
1025.
16sabya2049@gmail.com11/30/2017
17sabya2049@gmail.com11/30/2017

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Analysis of lisinopril by UV Sphectrometry

  • 1. Development AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF LISINOPRIL IN BULK AND PHARMACEUTICAL FORMULATION SABYA SACHI DAS PhD Scholar Dept. Of Pharm. Sci. & Tech. Birla Institute Of Technology Mesra,Ranchi-835215,Jharkhand
  • 2. introduction  Simple UV-Spectrophotometric methods was developed for the determination of Lisinopril in bulk and its pharmaceutical dosage forms.  Lisinopril exhibited maximum absorption at 241nm by UV spectroscopy using 0.1N NaOH as the solvent.  The drug obeys linearity in the concentration ranges of 5-60 g/ml. 2sabya2049@gmail.com11/30/2017
  • 3. Drugprofile LISINOPRIL Pharmacokinetics data: Bioavailability: Approximately 25% Metabolism: Does not undergo metabolism, it is excreted unchanged entirely in urine. Half- life: 10-12 hours Excretion: Renal 3sabya2049@gmail.com11/30/2017
  • 4. Chemical data: Empirical formula : C21H31N3O5 Molecular weight : 405.5 gm/mole Physical stability: Colour : White to off-white. Solubility : Soluble in water, sparingly soluble in methanol, practically insoluble in ethanol. Melting point : 146-148 ⁰C Form : Crystalline powder λ max : 241nm (uv) 4sabya2049@gmail.com11/30/2017
  • 5. Pharmacological action:  Lisinopril inhibits angiotensin converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II.  Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin- aldosterone system.  Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. Category : ACE INHIBITOR (Anti hypertensive drug) 5sabya2049@gmail.com11/30/2017
  • 6. LITERATUREREVIEWON LISINOPRIL The Intraday and Interday precision for Lisinopril and its active metabolite were found to be 0.213±0.0028 and 0.204±0.0019 respectively. Correlation co-efficient for Lisinopril was found to be 0.9994. %RSD for lisinopril was found to be 1.314. HPLC method was validated according to the guidelines of Food and Drug Administration, showing to be accurate (bias within ±12%)over the concentration range of 5-60 μg/mL for Lisinopril. Absorbance was monitored at 241 nm where Lisinopril has maximum absorption. Tablet dosage form was estimated, and percentage recovery was 98.4-99.87%. 6sabya2049@gmail.com11/30/2017
  • 7. Parameters Obtained values Λmax 241nm Beer’s Law limit (g/ml) 5.60 Sandell’s sensitivity (g/cm2/0.001 AU) 0.0121 Molar Extinction Coefficient (L.mole-1.cm-1) 2.083×10-4 % RSD 1.314 Regression equation (Y)* 0.0096x+0.0192 % Range of error 0.05 confidence limits 0.01 confidence limits ± 0.00156 ± 0.01293 Correlation co-efficient 0.9994 OPTICAL CHARACTERISTICS FOR LISINOPRIL: 7sabya2049@gmail.com11/30/2017
  • 8. LINEARITYTABLEFORLISINOPRILBY UV SPECTROPHOTOMETRICMETHOD CONCENTRATION (µg/ml) ABSORBANCE AT 241 nm 5 0.065 10 0.121 20 0.213 30 0.301 40 0.395 50 0.499 60 0.598 8sabya2049@gmail.com11/30/2017
  • 9. CALIBRATIONCURVEOF LISINOPRILBY UV SPECTROPHOTOMETRICMETHODIN 0.1NNaOHAT 241 nm 0.065 0.121 0.213 0.301 0.395 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 0.45 0 10 20 30 40 50 Aborbance(at241nm) Concentration(µg/ml) Calibration curve of Lisinopril by UV spectrophotometry(Method-I) 9sabya2049@gmail.com11/30/2017
  • 10. LISINOPRILIN COMMERCIALFORMULATION FORMUL -ATION LABELED AMOUNT (mg) OBSERVED AMOUNT (mg) ±S.D % RECOVE- RY ± S.D. %R.S.D PRINIVIL TABLET 5 mg 4.98 ± 0.0122 99.6 ± 0.1102 0.1106 10sabya2049@gmail.com11/30/2017
  • 11. Precision The precision of the proposed method was ascertained by actual determination of six replicates of fixed concentration of the drug within the Beer’s range and finding out the absorbance's by the proposed method. From these absorbance's Mean, Standard deviation and %R.S.D was calculated. 11sabya2049@gmail.com11/30/2017
  • 12. ResultsinPrecision PRECISION CONCENTRATI ON (µg/ml) METHOD-I (MEAN ± SD) METHOD-II (MEAN ± SD) RSD(%) INTRADAY 20 0.213 ± 0.0028 20.112 ± 0.0121 1.314 INTERDAY 20 0.204 ± 0.0019 20.011 ± 0.0221 0.931 12sabya2049@gmail.com11/30/2017
  • 13. ACCURACY  To determine the accuracy of the proposed method, recovery studies were carried out by taking different amounts (80%, 100% and 120%) of bulk samples of Lisinopril within the linearity range and adding to the pre-analyzed formulation concentration.  From that percentage recovery values were calculated. 13sabya2049@gmail.com11/30/2017
  • 14. RESULT IN ACCURACY SAMPLE ID CONCENTRATION (µg/ml) %RECOVERY OF PURE DRUG STATISTICAL ANALYSIS Pure drug Formulation S1: 80% 8 10 98.45 MEAN= 98.36 SD =0.3286 %RSD = 0.3340 S2: 80% 8 10 98 S3: 80% 8 10 98.64 S4: 100% 10 10 100.12 MEAN= 100.45 SD = 0.6715 %RSD= 0.6684 S5: 100% 10 10 100.23 S6: 100% 10 10 100.02 S7: 120% 12 10 101.23 MEAN= 100.26 SD = 0.864 %RSD= 0.8617 S8: 120% 12 10 99.56 S9: 120% 12 10 100.01 14sabya2049@gmail.com11/30/2017
  • 15. CONCLUSION  The proposed method is simple, sensitive and reliable with good precision and accuracy.  The proposed method is specific while estimating the commercial formulations without interference of excipients and other additives.  Hence, this method can be used for the routine determination of Lisinopril in bulk samples and Pharmaceutical formulations. 15sabya2049@gmail.com11/30/2017
  • 16. REFERENCE  GRChatwal, S Anand, Instrumental Methods of Chemical Analysis; 2002:209-217.  Scottish intercollegiate guidelines network (sign), control of pain in adults with cancer-a national clinical guideline. Scotland national health service (nhs).2008:76-89.  G. T. Warner and B. Jarvis, Olmesartan medoxomil, Drugs 62 (2002) 1345–1353.  Sissmann j, bouroudian m, armagnac c, donazollo y, latreille m, and panis r. Angiotensin ii blockade in healthy volunteers: tolerability and impact on renin angiotensin system components of single and repeated doses of a new angiotensin ii receptor antagonist sr 47436 (bms 186295). J hypertens 1994; 12: s92.  Metabocard for lisinopril retrieved 29 april 2004: 1010- 1025. 16sabya2049@gmail.com11/30/2017