Stability Indicating Method for Simultaneous RP HPLC Determination of Camylofin Dihydrochloride and Nimesulide in Pharmaceutical Preparations

Abstract EN

A simple, fast, and precise reversed phase high-performance liquid chromatographic method has been developed for the simultaneous determination of camylofin dihydrochloride and nimesulide using caffeine as an internal standard.

The stability indicating capability of the method was proved by subjecting the drugs to stress conditions as per ICH-recommended test conditions.

Separation was achieved using Varian Chromspher 5 C18 column (250 mm × 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of buffer solution pH 5.0 : methanol (600 : 400, v/v) at a flow rate of 1.0 mL min−1, column temperature of 30∘C and UV detection at 220 nm.

The retention time of caffeine, camylofin dihydrochloride, and nimesulide was about 5.0 min, 6.1 min, and 12.7 min, respectively.

The proposed method was validated for linearity, accuracy, precision, sensitivity, robustness and solution stability.

Linearity, accuracy, and precision were found to be acceptable over the ranges of 250–750 μg mL−1 for Nimesulide and 125–375 μg mL−1 for camylofin dihydrochloride.

The test solution was found to be stable for 72 h.

It can be conveniently adopted for routine quality control analysis.