This work is intended to thrive a stability-indicating high performance liquid chromatographic method for the analysis of Raloxifene HCl related compounds in pharmaceutical dosage forms. The separation was achieved Inertsil C8 (150 x 4.6 mm ID, 3.5μm)column using a gradient method. Mobile phase A is 0.01M KH2PO4 buffer (pH4.5), and mobile phase B is acetonitrile used in this work. 1.0 mL/ minute is the flow of rate and at 280nm noticed wavelength is monitored. For specificity, the limit of quantification, the limit of detection, linearity, accuracy, method precision, intermediate precision, robustness and stability this method is validated. The six injection impurities of standard solutions at the 4.0 µg/mL conjecture concentration were confirmed experimentally for LOQ values. The correlation coefficient of the impurities is more than 0.99. All impurities meet the criteria for linearity of both the impurities and raloxifene. The RSD recoveries obtained for impurities are not more than 10%. The achievement of this study demonstrated that the method is selective, linear, precise, rugged, robust and stability-indicating for the determination of related substances in raloxifene HCl tablet dosage form.

A selective, rapid and sensitive method was developed for the determination of genotoxic impurities (2-Amino-6-chloro purine and Bromo compound) in Penciclovir drug substance using RPUPLC-MS/MS. The chromatographic separation was performed on Kromasil C8 column (150 mm x 4.6 mm, 5 μm) maintained at 45°C using 0.1%formic acids in water as buffer and acetonitrile through gradient programme. The flow rate was maintained at 0.5mL/min with an injection volume of 10 μL. For the quantification of genotoxic impurities, positive-electrospray ionisation (ESI) mode was selected. Penciclovir and its impurities were well separated within the shortest run time of 16min. The chromatographic method was developed, and the results of all validation parameters showed that the technique is well confined to the limits of ICH guidelines. The method has high sensitivity, and the limit of detection was found to be as low as 0.15 and 0.30 ppm for 2-Amino-6-chloro purine and Bromo compound. The recovery of 2-Amino-6-chloro purine and Bromo compound are found in the range of 80-120%. The linearity of peak area versus concentration was demonstrated in the range of LOQ - 150% level of impurities with a correlation coefficient of 0.9999. The method has proved too robust by introducing minuscule changes in the chromatographic parameters. The method was successfully validated and applied for Penciclovir drug substances and their dosage forms to determine the mentioned genotoxic impurities.