A Novel, Rapid, and Validated Stability-Indicating UPLC Method for the Estimation of Drotaverine Hydrochloride and Ibuprofen Impurities in Oral Solid Dosage Form

Rekulapally Vijay Kumar; Vinay U Rao; N Anil Kumar; B Venkata Subbaiah

doi:10.3797/scipharm.1503-02

A Novel, Rapid, and Validated Stability-Indicating UPLC Method for the Estimation of Drotaverine Hydrochloride and Ibuprofen Impurities in Oral Solid Dosage Form

Sci Pharm. 2015 Apr 13;83(4):567-81. doi: 10.3797/scipharm.1503-02. Print 2015 Oct-Dec.

Authors

Rekulapally Vijay Kumar¹, Vinay U Rao², N Anil Kumar², B Venkata Subbaiah²

Affiliations

¹ Department of Chemistry, J.N.T. University, Kukatpally, Hyderabad-500085, A.P, India.
² Dr. Reddy's Laboratories Ltd. IPDO, Bachupally, Hyderabad-500090, A.P, India.

Abstract

A novel, stability-indicating, reversed-phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of pure drotaverine hydrochloride and ibuprofen in the presence of their impurities and degradation products. The method was developed using a Waters UPLC BEH C18, 100 × 2.1 mm, 1.7 µm column with a flow rate of 0.3 mL/min and detector wavelength at 210 nm. The mobile phase consisted of potassium dihydrogen orthophosphate buffer and acetonitrile. Drotaverine hydrochloride and ibuprofen were subjected to the stress conditions of oxidative, acid, base, photolytic, and thermal degradation. Degradation products resulting from the stress studies were well-resolved, thus confirming the test method as stability-indicating. Validation of the method was carried out as per International Conference on Harmonization guidelines.

Keywords: Drotaverine; ICH guidelines; Ibuprofen; Impurities; RP-HPLC; Stability-indicating.