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Volume 81
Issue 4
10.3797/scipharm.1305-19
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Article

Development and Validation of a Stability-Indicating Assay of Etofenamate by RP-HPLC and Characterization of Degradation Products

by
Ramalingam PERAMAN
1,
Devanna NAYAKANTI
2,
Hari Hara THEJA DUGGA
1,* and
Sudhakara KODIKONDA
1
1
Analytical Research Laboratory, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur (JNTUA), Andhra Pradesh – 515721, India
2
Jawarharlal Nehru Technological University Anantapur, Andhra Pradesh – 515001, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2013, 81(4), 1017-1028; https://doi.org/10.3797/scipharm.1305-19
Submission received: 17 May 2013 / Accepted: 22 July 2013 / Published: 22 July 2013
Versions Notes

Abstract

A validated stability-indicating RP-HPLC method for etofenamate (ETF) was developed by separating its degradation products on a C18 (250 mm × 4.6 mm 5 μm) Qualisil BDS column using a phosphate buffer (pH-adjusted to 6.0 with orthophosphoric acid) and methanol in the ratio of 20:80 % v/v as the mobile phase at a flow rate of 1.0 mL/min. The column effluents were monitored by a photodiode array detector set at 286 nm. The method was validated in terms of specificity, linearity, accuracy, precision, detection limit, quantification limit, and robustness. Forced degradation of etofenamate was carried out under acidic, basic, thermal, photo, and peroxide conditions and the major degradation products of acidic and basic degradation were isolated and characterized by 1H-NMR, 13C-NMR, and mass spectral studies. The mass balance of the method varied between 92–99%.
Keywords: Etofenamate; Stability; RP-HPLC; NMR; Mass spectral studies Etofenamate; Stability; RP-HPLC; NMR; Mass spectral studies

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MDPI and ACS Style

PERAMAN, R.; NAYAKANTI, D.; DUGGA, H.H.T.; KODIKONDA, S. Development and Validation of a Stability-Indicating Assay of Etofenamate by RP-HPLC and Characterization of Degradation Products. Sci. Pharm. 2013, 81, 1017-1028. https://doi.org/10.3797/scipharm.1305-19

AMA Style

PERAMAN R, NAYAKANTI D, DUGGA HHT, KODIKONDA S. Development and Validation of a Stability-Indicating Assay of Etofenamate by RP-HPLC and Characterization of Degradation Products. Scientia Pharmaceutica. 2013; 81(4):1017-1028. https://doi.org/10.3797/scipharm.1305-19

Chicago/Turabian Style

PERAMAN, Ramalingam, Devanna NAYAKANTI, Hari Hara THEJA DUGGA, and Sudhakara KODIKONDA. 2013. "Development and Validation of a Stability-Indicating Assay of Etofenamate by RP-HPLC and Characterization of Degradation Products" Scientia Pharmaceutica 81, no. 4: 1017-1028. https://doi.org/10.3797/scipharm.1305-19

APA Style

PERAMAN, R., NAYAKANTI, D., DUGGA, H. H. T., & KODIKONDA, S. (2013). Development and Validation of a Stability-Indicating Assay of Etofenamate by RP-HPLC and Characterization of Degradation Products. Scientia Pharmaceutica, 81(4), 1017-1028. https://doi.org/10.3797/scipharm.1305-19

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