Introduction. Justification of the study. Problem statement. Objectives of the study. Materials and Methods. Result and Discussion. Conclusion. Recommendation.

1. Comparative in Vitro Evaluation of Some
Commercial Brands of Valsartan Tablets
Marketed in Gaza Strip.
By :
Moeen J. Emghari Ibraheem Abd Alaziz
Marwa A. Nashwan Alaa N. Boraei
Supervised by:
Dr.Areij emsalem Dr. Elham Abu WakedDr. Nahedh
Hijazy

2. Outline:
Introduction.
Justification of the study.
Problem statement.
Objectives of the study.
Materials and Methods.
Result and Discussion.
Conclusion.
Recommendation.

3. Introduction
Valsartan is an oral medication that is used to treat high blood pressure and
congestive heart failure. It belongs to a class of drugs called angiotensin II
receptor blockers (ARBs).
Quality control (QC) is a procedure or set of procedures intended to ensure that
a manufactured product or performed service adheres to a defined set of quality
criteria or meets the requirements of the GMP(good manufacture process) and
pharmacopeia. To achieve efficacy, safety for products.

4. Justification of the study
• The marketing of drug product from multisource with competitive
pricing in Gaza strip might be chance of presence of some superiors
along with sub-standard drugs and the chronic use of valsartan tablets
creates the need to monitor and ascertain the quality of the various
brands.
• Therefore, the present study was performed to evaluate and compare
the quality parameters of three different brands of valsartan tablet.

5. Problem statement
• The quality of pharmaceuticals is a global concern; counterfeit
medicines are increasingly detected worldwide. Quality of
pharmaceutical product is the most essential for efficacy and
safety of product. With respect to the widespread use of valsartan
tablet, as antihypertensive drug. Quality parameters of different brands
available in Gaza Strip should be studied.

6. Objectives of the study:
General objective:
 To evaluate the quality of three different commercial brands of Valsartan
tablets marketed in Gaza strip using in vitro method.
 To Compare between three marketed brands.
Specific objectives:
1. Determination the quality parameters of valsartan tablet using different tests (Weight
variation, Hardness, Thickness & diameter, Friability, Disintegration time, Assay,
Dissolution).
2. Comparison between the quality of different brands of valsartan tablets marketed in
Gaza.
3. Investigation the reasons for the difference between the alternatives.
4. Determination which of three bands is more economic and effective based on the results.

7. Materials and Methods
• Materials:
Chemical:
Standard of valsartan powder.
Sampling:
 Multinational brands of Valsartan 80mg were collected randomly from different pharmacies.
 The samples were checked for their batch number, manufacturing and expiry dates, pack size and
price per pack.
Solvents and reagents:
 Phosphate buffer (pH 6.8), that will be used in this study of analytical-reagent grade and
 distilled water will also be used during the study.

8. Methods
1. Determination of diameter and thickness.(micrometer)
 According to (USP), 20 tablets were taken from different brands,
 Measured the diameter and thickness of the tablets with micrometers.
 Calculated the deviation of diameter % and deviation of thickness %
2. Weight variation test.(balance)
 According to (USP), 20 tablets were taken from different brands.
 weighed with balance.
 Calculated the percentage Standard Deviation of Weight.

9. Methods
3. Hardness test.(Hardness tester)
 Determine hardness for 10 tablet from each brand by Hardness tester
 Calculated the average of hardness for each brand.
4. Disintegration test.(Disintegration apparatus)
 6 tablets were taken from each brand and placed in the disintegration
room basket.
 The vessel filled with distilled water and heated at temperature 37 ±
0.50 ° C.
 Recorded as the time that no particle remains on the system basket.

10. Methods
5. Calibration Curve.(spectrophotometer)
 Prepare 6 different concentrations of valsartan from valsartan standard
 measuring the absorbent on UV spectroscopy at 250 nm.
 put the data on excel to get an equation of Calibration Curve.
6. Dissolution test.(Dissolution apparatus)
 The vessels filled with 900ml phosphate buffer (pH 6.8) and maintained
temperature at 37 ± 0.5 ° C.
 One tablet from each brand placed inside the vessel.
 5 mL of sample was withdrawn from the vessel every 5 minutes.
 Measuring the absorbent on UV spectroscopy at 250 nm.
 Determine the concentration by the calibration curve equation.

11. Result and Discussion
1. Diameter and thickness:
Comparison Brand A Brand B Brand C Accepted result
USP
Average of thickness 3.46 mm 4.22 mm 4.53 mm
Standard Deviation OF
Thickness %
-1.17 to 1.71 -4.40 to 3.64 -0.77 to 0.14 not exceed ±5%
Average of Diameter
8.15 mm 8.11 mm 8.59 mm
Standard Deviation OF
Diameter %
-0.28 to 0.44 -0.90 to 0.45 -0.15 to 0.08 not exceed ± 5%

12. Result and Discussion
2. Weight variation test:
USP standards Difference% Allowed
130 mg or less ±10%
130 mg – 324 mg ±7.5%
More than 325 mg ±5%
Comparison Brand A Brand B Brand C Accepted
result
Average of Weight 162 mg 207 mg 247 mg
Standard Deviation of
Weight %
-2.81 to 3.47 -3.54 to 3.60 -1.90 to 2.34 ±7.5%

13. Result and Discussion
3. Hardness test.
Comparison Brand A Brand B Brand C Accepted result
USP
Average of
hardness
6.55 kg/cm2 7.77 kg/cm2 7.73 kg/cm2 5-8 kg/cm2
4. Disintegration test.
Comparison Brand A Brand B Brand C Accepted result
USP
Disintegration
time
90 seconds 45 seconds 150 seconds Not more than
30 minutes

14. Result and Discussion
5. Calibration Curve.
y = 0.0312x + 0.0101
y = 0.0312x + 0.0101
R² = 0.9906
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0 5 10 15 20
Absorbance
Concentration (mcg/ml)
Calibration curve of ValsartanConcentration
(µgm/ml) Absorbance
0 0
2 0.091
4 0.113
6 0.208
8 0.259
10 0.333
12 0.38
14 0.463
16 0.472
18 0.586
y = absorbance
X=Concentration

15. Result and Discussion
6. Dissolution test. 80
83
86
89
92
95
98
101
104
107
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70
ConcentrationDrugRelase)%(
Time (min)
Dissolution Curve
A B C
Brand A
Time in
minutes
Concentration
drug releases
%
5 90.59
10 93.48
20 93.84
30 97.45
40 97.45
50 99.26
60 99.98
Brand B
Time in
minutes
Concentration
drug releases
%
5 98.18
10 89.87
20 92.76
30 97.09
40 97.82
50 99.62
60 100.34
Brand C
Time in
minutes
Concentration
drug releases
%
5 94.57
10 88.07
20 85.90
30 86.62
40 93.12
50 97.09
60 99.98
Accepted result
USP
Not less than 80%
after 30 min

16. Conclusion
• Brand of B had the highest crushing strength and lowest disintegration time and
best dissolution rate compared to the other brands according to this result brand B
well give higher absorption rate and higher bioavailability.
• Three brands (A,B,C) complied with USP specifications for the thickness and
diameter test, weight variation test, hardness test, disintegration time and
dissolution test of the tablets.
• We conclude from the results, three brands complied with the pharmacopoeia
specification of different parameters.

17. Recommendation
• We recommend bioequivalence in vivo study to ensure the bioavailability and
bioequivalence for this brands.
• All the brands complied with the pharmacopoeia specification of different
parameters, the doctor can prescribe any of them to the patient safely.