IN VITRO ASSESSMENT OF PHYSICOCHEMICAL PARAMETERS OF FIVE GENERICS AMLODIPINE BESYLATE TABLETS MARKETED IN YEMEN

Authors

  • ARWA ALSHARGABI Department of Pharmacy, Faculty of Medical Sciences, Al-Nasser University, Sana’a, Yemen

DOI:

https://doi.org/10.22159/ijpps.2021v13i11.42898

Keywords:

Amlodipine; Quality control; United stat of pharmacopeia, Hypertension.

Abstract

Objective: The present paper aims to evaluate the quality of five different brands (local and imported) of oral film-coated tablets of generic Amlodipine besylate 5 mg marketed in Sana`a-Yemen, through physiochemical parameters.                                                          

Methods: Different physicochemical parameters including the uniformity of tablet weight, hardness, thickness, disintegration time, and an assay of active ingredients were conducted to validate the quality of generics Amlodipine Besylate 5 mg according to USP specification.

Results: From the obtained results, it was observed that all the brands of Amlodipine Besylate 5 mg have passed the tests and met the specifications of USP. Results of weight variation, hardness, thickness, and disintegration time were ranged from -3.8 % to + 5.13 % to -1.25 % to +3.25 %, 5.06 ± 0.31 to 13.21 ± 1.5,  2.682 ± 0.04 to 3.676 ± 0.01 and 25 s to 2 min:30 s, respectively. The dissolution test and the assay results of all the brands are also ranged within the acceptable label claim 93.7 ± 2.24 to 98.4 ± 0.85 and 93.22 ± 0.38 to 100.15 ± 0.33, respectively. However, there is no relation was found between the disintegration time and the dissolution test.

Conclusion: According to the finding, all the selected Amlodipine Besylate 5 mg brands are met pharmacopeia standards and USP specifications. Therefore, the local and imported Amlodipine Besylate 5 mg can be used safely to get the desired therapeutic efficiency.

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Published

04-10-2021

How to Cite

ALSHARGABI, A. “IN VITRO ASSESSMENT OF PHYSICOCHEMICAL PARAMETERS OF FIVE GENERICS AMLODIPINE BESYLATE TABLETS MARKETED IN YEMEN”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 13, no. 11, Oct. 2021, doi:10.22159/ijpps.2021v13i11.42898.

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Original Article(s)