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Development and Validation of RP-HPLC Method for Quantitative Analysis Tolbutamide in Pure and Pharmaceutical Formulations

D. Madhu Latha, K. Ammani and P. Jitendra Kumar

A validated simple, sensitive, specific and precise RP-HPLC method was developed for the determination of Tolbutamide in pure and pharmaceutical formulations. Analysis was carried on Zodiac C18 column (250 mm × 4.6 mm × 5 µ particle size) using Methanol : 0.1% Orthophosphoric acid : Acetonitrile (10 : 30 : 60) as mobile phase. Detection was carried out by U.V at 231 nm. The proposed method obeyed linearity in the range of 20-120 µg/mL and met all specifications as per ICH guidelines. Statistical analysis revealed that this method can be used in routine quality control studies of Tolbutamide in pure and its formulations.