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Sci. Pharm. 2012, 80(4), 965-976; doi:10.3797/scipharm.1207-12

Novel Validated Stability-Indicating UPLC Method for the Estimation of Naproxen and its Impurities in Bulk Drugs and Pharmaceutical Dosage Form

1
Dr. Reddy's Laboratories Ltd. IPDO, Bachupally, Hyderabad-500072, A.P, India
2
Department of Chemistry, J. N. T. University, Kukatpally, Hyderabad-500072, A.P, India
*
Author to whom correspondence should be addressed.
Received: 16 July 2012 / Accepted: 9 September 2012 / Published: 9 September 2012
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Abstract

A novel, reversed-phase ultra-performance liquid chromatographic method was developed and validated for the determination of related substances in Naproxen (NAP) bulk drugs and dosage forms. The related substances included degradation and process-related impurities. The method was developed using the Waters Acquity BEH C18 column using the gradient program with mobile phase A of a pH 7.0 phosphate buffer and methanol in the ratio of 90: 10 (v/v) and mobile phase B as methanol and acetonitrile in the ratio of 50:50 (v/v). Naproxen and its impurities were monitored at 260 nm. Naproxen was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, humidity, and photolytic degradations. The degradation products were well-resolved from the main peak and its impurities, proving the stability-indicating power of the method. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness, and robustness.
Keywords: Naproxen; Validation; UPLC; Stability-indicating; Degradation Naproxen; Validation; UPLC; Stability-indicating; Degradation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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VENKATARAO, P.; NAGENDRA KUMAR, M.; RAVI KUMAR, M. Novel Validated Stability-Indicating UPLC Method for the Estimation of Naproxen and its Impurities in Bulk Drugs and Pharmaceutical Dosage Form. Sci. Pharm. 2012, 80, 965-976.

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