Abstract

Analytical method development is a vital part of pre-formulation and formulation development research. Development of validated, robust, cost-effective methodologies for routine drug estimations is the urgent need of the pharmaceutical R&Ds. Quality is an essential attribute in any pharmaceutical product and impurity profiling offers a broad scope with the changed perspectives of the research scenario. The present work aims to devise a validated UV-spectroscopic and RP–HPLC method for estimations of SVN in bulk and formulations and impurity profiling of SVN related impurities at the specification limit with the aid of response surface methodology. The percent assay for SVN determined by UV method was 100.4±0.15 and mean %recovery was achieved to be 99.87±0.19. The percent assay of SVN by RP-HPLC method was found to be 100.14±0.1. The mean percent recovery at different spike levels (50–150%) ranged from 97.3±0.01–100.5±0.02 and the %RSD of assays at lower and higher spike levels were 1.4 and 0.3 respectively. The linearity data of impurities (A–G) at different spike levels (25, 50, 100, 125 and 200 µg) showed a high correlation coefficient of 0.99 in all cases. Percent mean recovery of impurities (A–G) at different spike levels comply the acceptance criterion. All other validation parameters also comply within the range of acceptable limits. The impurities were well separated with good resolution and peak shape, good retention times. The robustness of the developed HPLC method and that of impurity profiling was optimized applying Box-Benkhen experimental design approach.

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