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WJPR

World Journal of Pharmaceutical Research

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology

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Abstract

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BRINZOLAMIDE IN BULK DRUGS

Dr. Shrikant M. Ghodse* and Kinjal K. Gawde

Abstract

A stability-indicating isocratic RP-HPLC method was developed and validated for the determination of Brinzolamide in bulk drugs using Hemochrom C18 column (150mm×4.6 mm, 5µm) with mobile phase consisting of 1mM ammonium formate: acetonitrile (76:24 v/v) with a flow rate of 1mL/min (UV detection at 254 nm). Linearity was observed over the concentration range 5-100 µg/mL (r2=0.9994) with regression equation y=15043x-3093. Brinzolamide was subjected to stress conditions including acidic, alkaline, oxidation, photolysis, and thermal degradation. Brinzolamide is more sensitive towards oxidative degradation. The method was validated as per the ICH guidelines.

Keywords: Brinzolamide; RP-HPLC; ICH; Validation; Forced degradation.

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