Application of Stability Indicating HPLC Method for Quantitative Determination of Etoricoxib and Paracetamol in Pharmaceutical Dosage Form

[摘要] A stability indicating reversed-phase HPLC method has been developed and subsequently validated for simultaneous estimation of etoricoxib (ETX) and paracetamol (PCT) from their combination product. The proposed RP-HPLC method utilizes a Phenomenex® C18, 5µm, 250mm X 4.6mm i.d. column, mobile phase consisting of acetonitrile, methanol and water in the proportion of 60:15:25 (v/v/v) and UV detection at 236.0 nm using a UV detector. Separation was completed within 10 minutes. ETX, PCT and their combination drug product were exposed to thermal, humidity, hydrolytic and oxidative stress conditions, the stressed samples were analysed by the proposed method. The described method was linear over a range of 8.3-41.5 µg/ml for PCT and 1-5 µg/ml for ETX with correlation coefficient value was found 0.9999 and 0.9993 respectively. The mean recoveries were 99.69±0.52 and 99.66±1.29 for PCT and ETX, repectively. The proposed method can be useful in the quality control of combination drug products.

[学科分类] 分析化学

[关键词] Sodium lignosulfonate;Inhibitor;Potentiodynamic polarization;Electrical conductance.