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 antiinflammatory
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.