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Sci. Pharm. 2013, 81(4), 1017-1028; doi:10.3797/scipharm.1305-19

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

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.
Received: 17 May 2013 / Accepted: 22 July 2013 / Published: 22 July 2013
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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
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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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.

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