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Sci. Pharm.
Volume 83
Issue 4
10.3797/scipharm.1503-02
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Article

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

by
Rekulapally VIJAY KUMAR
1,*,
Vinay U. RAO
2,
N. ANIL KUMAR
2 and
B. VENKATA SUBBAIAH
2
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
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2015, 83(4), 567-581; https://doi.org/10.3797/scipharm.1503-02
Submission received: 1 March 2015 / Accepted: 13 April 2015 / Published: 13 April 2015
Versions Notes

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; Ibuprofen; RP-HPLC; Stability-indicating; Impurities; ICH guidelines Drotaverine; Ibuprofen; RP-HPLC; Stability-indicating; Impurities; ICH guidelines

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MDPI and ACS Style

KUMAR, R.V.; RAO, V.U.; KUMAR, N.A.; SUBBAIAH, B.V. 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, 83, 567-581. https://doi.org/10.3797/scipharm.1503-02

AMA Style

KUMAR RV, RAO VU, KUMAR NA, SUBBAIAH BV. A Novel, Rapid, and Validated Stability-Indicating UPLC Method for the Estimation of Drotaverine Hydrochloride and Ibuprofen Impurities in Oral Solid Dosage Form. Scientia Pharmaceutica. 2015; 83(4):567-581. https://doi.org/10.3797/scipharm.1503-02

Chicago/Turabian Style

KUMAR, Rekulapally VIJAY, Vinay U. RAO, N. ANIL KUMAR, and B. VENKATA SUBBAIAH. 2015. "A Novel, Rapid, and Validated Stability-Indicating UPLC Method for the Estimation of Drotaverine Hydrochloride and Ibuprofen Impurities in Oral Solid Dosage Form" Scientia Pharmaceutica 83, no. 4: 567-581. https://doi.org/10.3797/scipharm.1503-02

APA Style

KUMAR, R. V., RAO, V. U., KUMAR, N. A., & SUBBAIAH, B. V. (2015). A Novel, Rapid, and Validated Stability-Indicating UPLC Method for the Estimation of Drotaverine Hydrochloride and Ibuprofen Impurities in Oral Solid Dosage Form. Scientia Pharmaceutica, 83(4), 567-581. https://doi.org/10.3797/scipharm.1503-02

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