Simultaneous Rp-HPLC determination of salicylamide, salicylic acid and deferasirox in the bulk API dosages forms
2015
Desai, N.C. | Senta, R.D.
The reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for simultaneous estimation of starting material, impurities and final product in bulk API forms. The proposed method utilizes waters symmetry C18 (250cm×4.6mm, 5μm) column, mobile phase consisting of buffer and acetonitrile in the proportion of 40:60 (v/v) with apparent pH adjusted to 3.2, and UV detection at 245nm. The described method was linear (r2≥0.99) over a range of 1–50μg/mL and relative standard deviation values for intra-day and inter-day precision studies were less than 1.0% for all ingredients. The analytical mean recoveries of salicylic acid, salicylamide and deferasirox by the developed RP-HPLC method were 99.74%, 99.52% and 99.40% respectively. This method was validated by evaluation of different parameters like specificity, accuracy, precision, system suitability, linearity, LOD and LOQ according to ICH guidelines. The method has been successfully applied for the analysis of drugs in pharmaceutical dosages forms.
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