Validated Stability-indicating RP-HPLC Method for the Determination of Parecoxib Sodium and Degradation Impurities in Bulk Drug

Background: Parecoxib sodium (PCX), the selective cyclooxygenase (COX)-2 inhibitor, has aroused great interests among researchers mainly because of its central role in analgesic and anti-inflammatory effects in a wide range of perioperative or postoperative procedures. The aim of the current study was to develop and validate a precise, accurate, and specific HPLC method systematically which could accomplish the stability indicating of PCX bulk drug and qualitation and quantization for the formed main impurity under the stressed conditions. Objective: Accomplishing the stability indicating of PCX bulk drug and qualitation and quantization for the formed main impurity under the stressed conditions. Methods: The study performed forced degradation testing on drug substances under varied conditions including alkali, acid, oxidation, photolysis, thermal and humidity using established stability-indicating high performance liquid chromatographic with photodiode array detector (HPLC-DAD). Results: The content of home-made bulk drug was 98.94% with RSD of 0.96% using our newly established method with respect to linearity, precision, specificity and accuracy. And we accomplished the stability indicating of PCX bulk drug and identified the newly formed main impurities including Impurity E (PCX), Impurity M, Impurity N, Impurity O, Impurity Q, and Impurity R under various stressed conditions. Conclusion: The stability-indicating HPLC method exhibited excellent performance, and the method was recommended for PCX bulk drug quality control analysis in the laboratory and pharmaceutical industry.