To develop and validate the stability indicating method for repaglinide and voglibose using HPLC method

Abstract

A simple, rapid, accurate, precise, robust and stability indicating Reverse phase High Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of Repaglinide and Voglibose in bulk drug and pharmaceutical dosage form was developed and validated. Chromatographic separation was achieved on a C18 column (250 × 4.6 mm, 5 µm) and used an isocratic mobile phase of a 40:60 v/v mixture of methanol and 0.1% orthophosphoric acid (OPA) with a flow rate of 1.0 mL/min and UV detection at 239 nm. The optimized chromatographic condition yields good peak resolution, satisfactory peak shape and plate number of Repaglinide and Voglibose peaks. The developed method was validated as per ICH-Q2(R2) guidelines for specificity, linearity, accuracy, precision, repeatability, ruggedness, robustness, limit of detection (LOD) and limit of quantification (LOQ). Both Repaglinide and Voglibose showed excellent linearity (Correlation Coefficient of close to 0.999) over the range of 5–25 µg/mL. The percentage recoveries were in the range of 99.25–100.82% for Repaglinide and 99.36–99.99% for Voglibose, with %RSD < 2% for precision, repeatability, robustness and ruggedness indicating reliability of the method. The forced degradation studies were carried out under acidic, alkaline, oxidative, neutral and photolytic conditions, showing adequate separation of degradation peaks from the drug peak thus proving the forced degradation method to be stability indicating. The validated method was successfully employed in the assay of marketed tablet formulations where the assay values were close to the labelled claim and reliable results were obtained for the routine quality control, assay determination and stability testing of Repaglinide and Voglibose in combination pharmaceutical formulations.