Development and Validation of UV-Spectroscopy and UHPLC Method for Gemfibrozil in Bulk Drug and Pharmaceutical Dosage Form

The present study attempts to validate the approach by UV-Spectroscopy at a wavelength of 273nm. The UHPLC separation was performed using reversed phase chromatography on a C18 column (100mmX4.6mm, 2.5m) in gradient mode at a flow rate of 1.0 mL min. At a wavelength of 273nm, diode array detection was performed using a mobile phase composed of a 50:50 (v/v) mixture of methanol and water (0.1% acetic acid).The technique for Gemfibrozil was linear in the concentration range of 5 - 25 g/ml, with a correlation coefficient of 0.9991. For Gemfibrozil, the limit of detection was 0.1058 g/ml. The limit of quantification for Gemfibrozil was 0.3208 g/ml. The analyte recovers at a rate of 98%-102% on average. The approach was found to be accurate, precise, specific, linear calibration curve, and resilient for both pure and pharmaceutical dosage forms. The method was validated in terms of linearity, recovery, accuracy, specificity, LOD/LOQ values, and solution stability, and it was effectively employed for Gemfibrozil determination. For Gemfibrozil, a simple, precise, accurate, and fast ultra high-performance liquid chromatographic (UHPLC) method has been designed and validated.