Pharmaceutical Analysis of Different Brands of Solifenacin Tablets Available in Pakistani Market

Muhammad Raza; Syed Baqir S. Naqvi; Muhammad Iqbal Nasiri; Tariq Ali; Kamran Zaheer; Ali Saleem; Humera Sarwar; Muhmmad Azeem

Muhammad Raza Hamdard University, Karachi, Pakistan
Syed Baqir S. Naqvi Hamdard University, Karachi, Pakistan
Muhammad Iqbal Nasiri Hamdard University, Islamabad Campus, Pakistan
Tariq Ali Dow University of Health Sciences, Karachi, Pakistan
Kamran Zaheer Hamdard University, Karachi, Pakistan
Ali Saleem Hamdard University, Karachi, Pakistan
Humera Sarwar Hamdard University, Karachi, Pakistan
Muhmmad Azeem Hamdard University, Islamabad Campus, Pakistan

Keywords: Solifenacin, pharmaceutical analysis, quality parameters, HPLC method

Abstract

Objective: The current study was designed to evaluate and compare the quality and physiochemical characteristics of three different most commonly used brands of Solifenacin (10 mg) tablets available in Karachi, Pakistan.
Methods: Both the official and non-official tests were applied for the assessment of physical tests, such as hardness, thickness, weight variation, friability, disintegration and chemical tests like dissolution profile and assay using already reported HPLC method. Model independent approach like similarity factor (f₂) was also applied to compare the dissolution profile of generic drug products with reference (innovator).
Results: The results of physical and chemical test showed that that all brands of Solifenacin were within the specified limits. The amount of Solifenacin in all three brands was within the USP specification of not less than 80% at 45 minutes. Similarly, the value of f₂ indicated that all the brands were found to be similar with reference (innovator).
Conclusion: This study will help physicians and pharmacists for the selection of most appropriate quality brand for the treatment of active urinary bladder and in-continence episodes of urination.