Characterization and Validation of Impurities in Pharmaceutical Bulk Drug by HPLC Methods
Journal Title: IOSR Journal of Applied Chemistry (IOSR-JAC) - Year 2018, Vol 11, Issue 2
Abstract
Three impurities were identified by HPLC methods. These impurities have process related or batch impurities. The identified impurities were found by two different chromatograms isolated by HPLC method. These impurities were not more than 0.3% and unspecified impurities are not more than 0.1%. These impurities were identified by using HPLC system; AR/VAL/HPLC-30, 31, Columns: C-18/AR/363, C-18/AR/369; Vacuum Oven (AR/LAB-I/VACO-01).Humidity Dessicator (AR/LAB-II/HDCR-01). Linearity range for Felodipine is 0.99990. LOD for Felodipine 0.003 & LOQ0.011, for Impurity-A, 0.003 &0.011, Impurity -B, 0.002 &0.005 and Impurity –C, 0.003 & 0.011. % RSD Values for Felodipine, impurities ABC is 4.30,5.87, 4.43 and 9.51. We have also calculated some parameters for validation such as identification, specificity, linearity, precision and system suitability.
Authors and Affiliations
Sushama R. Ambadekar, Iyer Balakrishnan, Manohar V. Lokhande
Keywords
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