Uhplc Method Development, Validation And Forced Degradation Study For Simultaneous Estimation Of Phentermine And Topiramate In Bulk And Tablet Dosage Form

Abstract

A novel approach was used to develop and validate a rapid, specific, accurate and precise Ultra Performance Liquid Chromatographic (UHPLC) method for the simultaneous determination of Phentermine and Topiramate in pharmaceutical dosage forms. The chromatographic separation was achieved on Aquity UPLC BEH C8 100 x 4.6 mm, 2.7μm, column using a mobile phase ammonium acetate Buffer PH 4.5:Acetonitrile:Methanol in the ratio of 60:20:20. The flow rate was 0.5 mL min−1 and the detection wavelength was 263 nm. The limit of detection (LOD) for phentermine and Topiramate was 0.46 and 1.97μg mL−1, respectively. The limit of quantification (LOQ) for phentermine and Topiramate was 1.5 and 6.51μg mL−1, respectively. This method was validated with respect to linearity, accuracy, precision, specificity, and robustness. The method was also found to be stability-indicating.