PHARMACEUTICAL ANALYSIS OF VARIOUS COMMERCIAL BRANDS OF DROTAVERINE: ENSURING PHARMACEUTICAL EQUIVALENCE
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Keywords
Drotaverine, BP/USP, quality control, symptomatic treatment.
Abstract
Background: Drotaverine (INN, also known as drotaverin), a benzylisoquinoline derivative, is an active antispasmodic compound. It exhibits stronger efficacy compared to papaverine and is commonly employed in the symptomatic treatment of various conditions. Drotaverine is utilized to alleviate pain associated with irritable bowel syndrome, headaches, menstrual periods, and is also effective in relieving cervical spasms during labor.
Objective of the Study: The aim of this study was to establish pharmaceutical equivalence among three distinct brands of Drotaverine HCL available in Pakistan.
Methodology: Seven key quality control parameters, including weight variation, thickness, hardness, friability, disintegration, and dissolution measured via UV spectrophotometer as per the standards defined by the British and United States Pharmacopeias, were assessed for the three different brands of Drotaverine HCL accessible in Karachi, Pakistan.
Results: The results demonstrate that the selected brands of Drotaverine HCL available in Karachi meet all specifications outlined by the B.P/USP.
Conclusion: Hence, these brands can be considered interchangeable with each other, ensuring consistent quality and efficacy for patients requiring Drotaverine therapy.
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Dr. Huma Dilshad
PhD Pharmaceutics Dean Research Department of Pharmaceutics Faculty of Pharmacy Jinnah University for Women
Noor Us Saba
PhD. Fellow, Department of Pharmacy Practice, Faculty of Pharmacy Jinnah University for Women
Javeria Sheikh
Lecturer, Department of Pharmaceutics Faculty of Pharmacy Jinnah University for Women
Najaf Farooq
Lecturer, Department of Pharmaceutics Faculty of Pharmacy, Sohail University
Asra Mansoor
Lecturer, Department of Pharmaceutics, Faculty of Pharmacy Jinnah University for Women
Qurat-ul-ain Waseem
Assistant Professor, Department of Pharmacy Practice, Faculty of Pharmacy Jinnah University for Women.
Nimra Waheed
Assistant Professor, Department of Pharmaceutics, Faculty of Pharmacy Jinnah University for Women.
Afreen Zafar
M. Phil. Pharmaceutics, Industrial Pharmacist, Department of Pharmaceutics, Faculty of Pharmacy Jinnah University for Women.