Abstract

DEVELOPMENT AND VALIDATION OF SOME PHARMACEUTICAL DRUGS BY STABILITY ASSAY METHOD

Vishwas Mohini, Sharma Ranu*, Garg Ayush, Kachawa Singh Vijay, Dr. Dwivedi Jayesh and Khathuriya Rajesh

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Abstract

A stability-indicating HPLC, UV and HPTLC assay method has been developed and validated for Metformin Hydrochloride and Benfotiamine in bulk drug and pharmaceutical dosage forms. An isocratic HPLC was achieved on Waters 2695 using Symmetry C18 (250mm × 4.6mm × 5μ) column with the mobile phase consisting of 0.02 mM sodium dihydrogen ortho-phosphate, pH adjusted to 2.5 using ortho-phosphoric acid (solvent A), and acetonitrile (solvent B) in the ratio of 58:42 %v/v. The stress testing of Metformin Hydrochloride and Benfotiamine was carried out under acidic, alkaline, oxidative, thermal, and photolytic conditions. Metformin Hydrochloride and Benfotiamine was well resolved from its degradation products. The proposed method was validated as per ICH guidelines. The method was found to be suitable for the quality control of Metformin Hydrochloride and Benfotiamine in bulk and pharmaceutical dosage forms as well as the stability-indicating studies.

Keywords: Stability assay (HPLC, UV and HPTLC), Metformin and Benfotiamine.