RP-HPLC Simultaneous Analysis of Glimepride and NSAIDs in Active Pharmaceutical Ingredient, Formulations and Human Serum

Abstract

The present work describes an innovative reversed phase High Performance Liquid Chromatographic (RP-HPLC) method for the determination of Non-steroidal antiinflammatory drugs NSAIDs with glimepride antidiabetic drug simultaneously in dosage formulations, active pharmaceutical ingredients and human serum. The chromatographic system consisted of Sil-20A auto sampler, LC-20A pump and SPD-20A UV/visible detector. The quantification was carried out by using a C18 (5 μm, 250 ×4.6 mm) column with mobile phase methanol: water (80:20 v/v, pH 3.0) at 228 nm with a flow rate of 1.0 mL•min–1. The retention time of glimepride was 12 min while of diclofenac sodium, ibuprofen and mefenamic acid were found to be 6.0, 8.0 and 10.0 minutes respectively. The method developed was found to be precise, accurate and selective and was validated for accuracy, precision, linearity, specificity, limit of detection and limit of quantitation. There is no such method reported earlier for the determination of glimepride and NSAIDs simultaneously. It was required for assessing the co-administration of both drugs in treatment and can be employed for drug-drug interactions studies.