This document presents the development and validation of a UV spectrophotometric method for the analysis of Irbesartan in tablet formulations. The method involves preparing standard and sample solutions of Irbesartan in 0.1N NaOH, scanning them from 200-400nm to obtain spectra, and measuring absorbance of the sample at 255nm. The method is linear from 5-40μg/ml. Accuracy, precision, specificity, robustness and degradation studies establish that the method is valid for analysis of Irbesartan in tablets.

1. Supervised by
Dr. B. Mohammed Ishaq
M.Pharm, Ph.D
Associate professor
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Presented by
P. Swathi
Reg.no. 12T11R0082
Co- Supervised by
Dr. Hindustan abdul ahad,
M.Pharm, Ph.D
principal
Balaji College of Pharmacy
almur road, rudrampeta bypass,
Anantapuramu

2. Contents
1. Introduction
2. Materials and methods
3. Results and discussion
4. Summary and conclusion
5. References
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4. 1. INTRODUCTION
 Pharmaceutical Analysis is the study of the separation,
identification, and quantification of the
Pharmaceutical compounds of natural and artificial
origin.
 Analytical chemistry is the science of making
quantitative measurements.
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5. 1.1. instrument principle
 Ultraviolet absorption spectra arise from transition of
electron with in a molecule from lower to higher
electronic energy level.
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6. 1.2. drug profile
 Irbesartan is an angiotensin II receptor antagonist
used in the management of hypertension including
treatment of renal disease in hypertensive type II
diabetic patients.
 Structure:
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7. 1.3. aim and objectives
 To develop a simple, reliable, precise, accurate and
economical method under routine conditions by UV
visible spectrometer.
 To validate the analytical method as per ICH
guidelines.
 To apply developed analytical method to marketed
formulation of Irbesarton
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8. 1.4. plan of work
 Selection of suitable common solvent .
 Which is readily available.
 chemically inert.
 economical and
 analytical grade for UV spectrophotometric method.
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10. 2. MATERIALS
 CT 60 Double beam UV-Visible spectrophotometer
 Sonicator
 Analytical balance
 Cuvvets
 Analytical grade chemicals and reagents
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11. METHODS
 An UV–Visible double beam spectrophotometer with
1cm matched quartz cells were used for the spectral
and absorbance measurements.
 Aqueous solutions were freshly prepared with triple
distilled water.
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12. 2.1. preparation of stock solution
 10 mg of drug dissolved in 10ml of 0.1N
NaOH.
 0.1 ml from above solution was taken and
make up to 10ml.
 0.2 ml was taken and made up to 10 ml to get
a concentration of 20 µg/ml.
 working standard solution of 20μg/ml for10ml
with 0.1N NaOH.
 The working standard solutions were daily
prepared by diluting stock solution in water.
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13. 2.2. preparation of test sample
 10 tablets were weighed and powdered. 10mg
of API = 26.98mg of tablet. It is transferred in
to 10ml of volumetric flask.
 0.1N NaOH was added up to 10ml and mixed
for 5-10 min and filtered.
 0.1 ml from the above stock solution was
transferred to 10 ml volumetric flask along with
0.1N NaOH. From the above solution 0.2ml was
transferred to 10 ml volumetric flask along with
0.1N NaOH to get 20µg/ml concentration.
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15. Acid degradation
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 3 samples of 20μg/ml drug solution +1ml of
0.1N HCL
Fig.1. Acid degradation Spectrum of Irbesarton
3.1.Degradation studies

16. Base degradation
 3 samples of 20μg/ml drug solution +1ml of
0.1N NAOH.
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Fig.2. Base degradation Spectrum of Irbesarton

17. Heat degradation
 3 samples of 20μg/ml drug solution heated for
1 hour.
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Fig.3. Heat degradation Spectrum of Irbesarton

18. Perioxide degradation
• 3 samples of 20μg/ml drug solution + 1ml 0f
H2O2
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Fig.4. Peroxide degradation Spectrum of Irbesarton

19. S. No Conc. (µg/ml) Absorbance
1 1 0.278
2 5.5 0.403
3 10 0.513
4 15.5 0.647
5 20 0.786
Linearity
Table 1: Calibration (Linearity) of Irbesarton
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20. 3/11/2019 20
Calibration curve of Irbesarton
Fig.5. Calibration curve of Irbesarton

21. 3/11/2019 21
S. No Conc. Level
Absorbanc
e
Amount
Added
(µg/ml)
Amount
Found
(µg/ml)
% Recovery
Mean %
Recovery
1
50
0.276 4.98 4.96 99.49
99.91
2 0.277 4.98 4.97 99.85
3 0.278 4.98 4.99 100.21
4 0.278 4.98 4.99 100.21
5 0.276 4.98 4.96 99.49
6 0.278 4.98 4.99 100.21
7
100
0.552 9.96 9.91 99.49
99.848 0.556 9.96 9.98 100.21
9 0.554 9.96 9.95 99.85
10
150
0.834 14.94 14.97 100.21
99.91
11 0.822 14.94 14.76 98.77
12 0.832 14.94 14.94 99.97
13 0.836 14.94 15.01 100.45
14 0.833 14.94 14.96 100.09
15 0.832 14.94 14.94 99.97
accuracy
Table 2: Accuracy results

22. 3/11/2019 22
S. No
Intraday Interday
Absorbance Absorbance
9:00 AM 1:00 PM 5:00 PM 1st Day 2 nd Day 3 rd Day
1 0.522 0.541 0.54 0.552 0.486 0.552
2 0.525 0.54 0.546 0.526 0.488 0.569
3 0.527 0.543 0.553 0.529 0.472 0.554
4 0.507 0.548 0.555 0.525 0.478 0.548
5 0.51 0.534 0.542 0.525 0.476 0.564
6 0.522 0.521 0.545 0.53 0.479 0.55
Averag
e 0.519 0.538 0.547 0.531 0.480 0.556
SD 0.008 0.009 0.006 0.010 0.006 0.008
% RSD 1.596 1.750 1.094 1.962 1.267 1.510
Precision
Table 3: Intraday Precision and interday precision

23. Concentration (μg/ml) Absorbance
5 0.152±0.001
10 0.251±0.002
20 0.505±0.001
30 0.721±0.001
40 0.938±0.001
All values mentioned as mean ± S.D; Number of
trials (n) =3
Calibration (Linearity) of Irbesarton
Table 4: Calibration (Linearity) of Irbesarton
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24. Slope 0.0227±0.009
Linearity R2= 0.999 (nearer to 1)
LOD 1.189µg/ml
LOQ 1.189µg/ml
Linearity values of Irbesarton calibration curve
Table 5: Linearity values of Irbesarton calibration curve
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25. 3/11/2019 25

26. 4. SUMMARY
 In this study simple, fast and reliable UV
spectrophotometric method was developed and
validated for the determination of Irbesarton in tablet
formulation.
 The method was applied directly to the analysis of
pharmaceutical dosage forms without the need for
separation such as extraction steps prior to the drug
analysis.
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27. conclusion
 we concluded that the suggested methods showed
high sensitivity, accuracy, reproducibility and
specificity. Moreover, these methods were simple and
inexpensive and they can be employed for the routine
quality control analysis of Irbesarton in
pharmaceutical formulations.
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31. Thank you
Presented
by
P.Swathi
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