Abstract
The aim of the present study was to develop and validate stability indicating HPLC method for simultaneous estimation of LevocloperastineFendizoate (LCP) and Chlorpheniramine Maleate (CPM). HPLC method for simultaneous analysis of both drugs was developed and validated according to ICH guideline. Efficient chromatographic separation was achieved on ODS column C18 (250 mm × 4.6 mm, 5 μm) using the optimized mobile phase. Stability indicating assay method was carried out by different stress degradation conditions. In HPLC method, the Retention time for LCP and CPM was 3.173 min and 5.060 min using optimized mobile phase Phosphate buffer (pH-3.5): Methanol (60:40 %v/v) and UV detection at 273 nm. The degradation of LCP, CPM and Formulation was shown to be highest in alkaline condition. Linearity was observed in concentration range of 20-80 μg/ml for LCP and 4-16 μg/ml for CPM. The correlation coefficient of LCP and CPM were respectively 0.9992 and 0.9994. All validation parameters were within the acceptable range. The LOD and LOQ values for HPLC method were found to be 0.146 μg/ml and 0.444 μg/ml for LCP and 0.0113 μg/ml and 0.0344 μg/ml for CPM respectively. The Method validation parameters showed %RSD value less than 2.
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