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Volume 80
Issue 4
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Article

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

by
Papanaboina VENKATARAO
1,2,*,
Morrisetty NAGENDRA KUMAR
1 and
Maram RAVI KUMAR
1
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.
Sci. Pharm. 2012, 80(4), 965-976; https://doi.org/10.3797/scipharm.1207-12
Submission received: 16 July 2012 / Accepted: 9 September 2012 / Published: 9 September 2012
Versions Notes

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

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MDPI and ACS Style

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. https://doi.org/10.3797/scipharm.1207-12

AMA Style

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. Scientia Pharmaceutica. 2012; 80(4):965-976. https://doi.org/10.3797/scipharm.1207-12

Chicago/Turabian Style

VENKATARAO, Papanaboina, Morrisetty NAGENDRA KUMAR, and Maram RAVI KUMAR. 2012. "Novel Validated Stability-Indicating UPLC Method for the Estimation of Naproxen and its Impurities in Bulk Drugs and Pharmaceutical Dosage Form" Scientia Pharmaceutica 80, no. 4: 965-976. https://doi.org/10.3797/scipharm.1207-12

APA Style

VENKATARAO, P., NAGENDRA KUMAR, M., & RAVI KUMAR, M. (2012). Novel Validated Stability-Indicating UPLC Method for the Estimation of Naproxen and its Impurities in Bulk Drugs and Pharmaceutical Dosage Form. Scientia Pharmaceutica, 80(4), 965-976. https://doi.org/10.3797/scipharm.1207-12

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