Research Articles

2023  |  Vol: 9(5)  |  Issue: 5(September-October)  |  https://doi.org/10.31024/ajpp.2023.9.5.1
Pharmaceutical equivalence study of eight brands of Candesartan Cilexetil tablets marketed in the United Arab Emirates

Fazilatun Nessa*, Susan George, Saeed Ahmed Khan

Pharmaceutical Chemistry Department, Dubai Pharmacy College for Girls, Dubai, United Arab Emirates

*Address for Correspondence         

Fazilatun Nessa, Ph.D.

Pharmaceutical Chemistry Department

Dubai Pharmacy College for Girls, Muhaisnah-1, PO BOX: 19099, Dubai, United Arab Emirates

 

Abstract

Objectives: This work aimed to develop a simple HPLC method and apply in the pharmaceutical equivalence study of seven imported and one local product of candesartan cilexetil tablets (4, 8 and 16 mg).  Methods: A simple RP-HPLC method was developed and validated in-terms of linearity, precision and accuracy, and applied in assay and dissolution study. The physical parameters and infrared scanning of the tablets were determined. The dissolution study was carried out at eight sampling data points to generate dissolution profiles for each brand and similarity factors of dissolution profiles were calculated. Results: The developed HPLC method was accurate and precise with ≤2% relative standard deviation observed in intra- and inter-day precision. In assay, the product contained 100.74 to 102.52% candesartan cilexetil and the acceptance value for dosage content uniformity were less than 15. The dissolution test at 45 minutes the tablet released >80% drug. The infrared spectrum of eight products showed the similarity in the presence of functional groups. The dissolution profiles generated with eight sampling data points were compared with a reference product. Two products in 8 mg strength and one in 16 mg strength had similarity factors ≥50% similar in dissolution pattern as the reference products and were deemed as pharmaceutical equivalent. Conclusion: The studied products met the quality standards based on the physical parameters, assay contents, dosage content uniformity and dissolution test results compared to the United States Pharmacopeia 44-National Formulary 39 specification. The local product was more affordable and had the same pharmaceutical quality as the reference product.

Keywords: Pharmaceutical equivalence, Candesartan Cilexetil, tablets, RP-HPLC, dissolution


 

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