Vol. 8, Issue 1 (2019)

Author(s):
P Bhaskararao and D Gowri Sankar

Abstract:
A simple and rapid stability indicating UPLC method has been developed and validated for simultaneous analysis of folic acid, atorvastatin and fenofibrate in bulk drug and in tablets. The separation and analysis of folic acid, atorvastatin and fenofibrate was done on a BEH C18 (2.1 mm × 100 mm, particle size 1.7 μm) with 0.1% orthophosphoric acid buffer (pH 3.5) and methanol (50:50percentage, v/v) as mobile phase at 0.5 ml/min flow rate. Detection was performed at 210 nm. Using the above stated chromatographic conditions, sharp peaks were obtained for folic acid, atorvastatin and fenofibrate with retention time 1.352 min, 1.563 min and 2.631 min, respectively. Good linearity was found in the range of 1.25-7.5 µg/ml for folic acid, 2.5-15 µg/ml for atorvastatin and 40-240 µg/ml for fenofibrate. Method was validated following ICH guidelines. The values of validation parameters are within the acceptance limits given by ICH. The tablet solution was subjected to diverse stress conditions using ICH strategy. The folic acid, atorvastatin and fenofibrate showed more percent of degradation in acid condition and less in neutral condition applied. The peaks of degradants did not interfere with the peaks of folic acid, atorvastatin and fenofibrate. The selected drug combination was assayed with good percentage of assay (Ì´ 100%) and low percent relative standard deviation (<2%) in tablets using the proposed method.