Development & Validation of Stability Indicating Assay Method for Quantitative Estimation of POLMACOXIB in Solid Dosage Form by RP-HPLC

Abstract

In order to quantification of Polmacoxib from its capsule formulation, a new simple, accurate, rapid and selective method indicating high-performance Liquid Chromatography (RP-HPLC) reverse-phase stability has been developed and validated. The separation of all degradation peaks was obtained on Inertsil ODS 3V (250mm × 4.6mm), 5μm column, using the gradient elution of ammonium acetate buffer (Mobile Phase - A) and Acetonitrile (Mobile Phase - B), with a flow rate of 1.5 ml/min and UV detection at 240 nm with a total run time of 28 minutes. Retention time of polmacoxib was found to be 10.8 min. Forced degradation of polmacoxib was carried out under acidic, basic, oxidative, thermal, photo degradation and humidity conditions. Polmacoxib has been found to degrade in oxidative degradation conditions. The method was validated for various parameters like system suitability, specificity, linearity, accuracy, precision, robustness, ruggedness as per ICH guidelines. The linear regression analysis data for the calibration plots showed a very good linear relationship with concentration range of 50 – 150 μg/mL with the linearity equation of Y = 19.658x + 3.434 (R2 = 0.999). The method was identified as sufficiently specific to separate degradation products from main analytes. Therefore, for the estimation of polmacoxib the developed stability indicating assay method by RP-HPLC can be used.