Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION – A REVIEW

Sai Rajesh K.*, Sushma Alapati, Konduru Sravani, Devineni Madhulika and Nuthakki Keerthi

ABSTRACT

HPLC is a crucial tool in analytical chemistry, widely used in the pharmaceutical industry for separating and quantifying compounds in liquid samples. HPLC, being the dominant separation technique in pharmaceutical and biomedical analysis, is highly efficient in achieving separations and, in most cases, provides high detection sensitivity. The HPLC methods are suitable for analyzing drugs in multi-component dosage forms. It plays crucial roles in the discovery, development, manufacture of pharmaceutical drugs It offers versatility, utilizes different methods of separation, and involves method development and validation. The validation of the HPLC method, following ICH Guidelines, covers all performance characteristics of validation. The characteristics include the celebrated Accuracy, utmost Precision, exclusive Specificity, superb Linearity, exceptional Range,
astonishing Limit of Detection, fascinating Limit of Quantification, unruly Robustness, and the incredible System Suitability Testing.

Keywords: HPLC, Pharmaceutical industry, Chromatography, Method development, Method validation.