Development and Validation of a Stability-Indicating Assay of Etofenamate by RP-HPLC and Characterization of Degradation Products.
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 (1)H-NMR, (13)C-NMR, and mass spectral studies. The mass balance of the method varied between 92-99%.
Analytical Research Laboratory, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur (JNTUA), Andhra Pradesh - 515721, India.
Ramalingam
R
Peraman
Jawarharlal Nehru Technological University Anantapur, Andhra Pradesh - 515001, India.
Devanna
D
Nayakanti
Analytical Research Laboratory, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur (JNTUA), Andhra Pradesh - 515721, India.
Hari Hara Theja
HH
Dugga
Analytical Research Laboratory, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur (JNTUA), Andhra Pradesh - 515721, India.
Sudhakara
S
Kodikonda
Etofenamate; Mass spectral studies; NMR; RP-HPLC; Stability