Satisfactory Essays
A simple, sensitive and accurate stability indicating RP-HPLC method for the simultaneous estimation of Simvastatin (SIM) and Fenofibrate (FB) in active pharmaceutical ingredients was developed on a Macherey-Nagel EC 250 x 4.6 mm nucleosil 100-5 C18 column and PDA detector operated at 247 nm wavelength. The acetonitrile-ammonium acetate buffer (8 mM, pH 4.3, 70:30, v/v) was used as mobile phase in isocratic mode with a flow rate of 0.7 mL/min and run time of 18 min. The combination of SIM and FB was subjected to stress degradation and the degraded products were separated and identified using LC-MS. Excellent separation of analytes (SIM and FB) form their degradation products proved the effectiveness of the developed stability indicating method. The developed method was validated according to ICH guidelines and can be applied for the quantification of SIM and FB in 10-60 µg/mL and 30-180 µg/mL range, respectively. Keywords Simvastatin, Fenofibrate, Stability indicating, RP-HPLC, LC-MS Simvastain (SIM), [1S [1α,3α,7β,8β(2S*,4S*),8αβ]]-1,2,3,7,8,8a-hexahydro-3, 7-dimethyl- 8- [2-(tetr...
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