Abstract

Chromatography, although primarily a separation technique, is mostly employed in chemical analysis, in which High-performance liquid chromatography (HPLC) is an extremely versatile technique where analytes are separated by passage through a column packed with micrometer-sized particles. Now a day reversed-phase chromatography is the most commonly used separation technique in HPLC. This article involves the strategies and the issues for designing HPLC method development and validation. HPLC methods should be able to separate, detect and quantify the various drug-related impurities that may be introduced during synthesis. The method development often follows the well established steps, like selection of buffer, selection mobile phase, selection of column. Method validation includes the parameters like accuracy, precision, linearity, LOQ and LOD, specificity etc. A number of chromatographic parameters were evaluated in order to optimize the method.

Keywords

HPLC, Method development, Validation, Impurity, Chromatography

Cite This Article

Mishra, K., Sing, B.K. (2016). A Review on Method Development and Validation by Using HPLC, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(3), 71-81.