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

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

Volume: 13 Issue: 3

Author(s): Qiuyang Yu, Qiuli Yu, Lei Wu, Jing Sun, Panqin Ma, Xiaojie Liu, Wenxiang Dong and Peng Zhang*

Affiliation:

• Mailbox 39#, Department of Pharmaceutical Analysis, School of Pharmacy, Shenyang Pharmaceutical University, No. 103 Wenhua Road, Shenyang, 110016,China

Keywords: HPLC-UV/DAD, parecoxib sodium, stability-indicating, degradation products, validation, titrimetric method.

Abstract: 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.

Cite this article as:

Yu Qiuyang, Yu Qiuli, Wu Lei, Sun Jing, Ma Panqin, Liu Xiaojie, Dong Wenxiang and Zhang Peng*, Validated Stability-indicating RP-HPLC Method for the Determination of Parecoxib Sodium and Degradation Impurities in Bulk Drug, Current Pharmaceutical Analysis 2017; 13 (3) . https://dx.doi.org/10.2174/1573412912666160418165539

DOI https://dx.doi.org/10.2174/1573412912666160418165539	Print ISSN 1573-4129
Publisher Name Bentham Science Publisher	Online ISSN 1875-676X