HPLC METHOD DEVELOPMENT VALIDATION AND STABILITY INDICATING FOR DETERMINATION OF ESOMEPRAZOLE IN CAPSULE

Dr. Amit Choudhary, Dr. Abhishek Soni, Priyankul Palia, *Suresh Kumar and Happy

ABSTRACT

HPLC produces highly efficient separations and, in most cases, high detection sensitivity, it is the most widely used separation technique in modern pharmaceutical and biomedical research. Because of its advantages such as rapidity, specificity, accuracy, precision, and ease of automation, the HPLC approach can be used to test the majority of drugs in multi-component dosage types. An analytical technique is created to compare a given characteristic of a drug substance or drug product to accepted acceptance criteria. This article discusses the different stages involved in the creation and validation of HPLC methods. Accuracy, precision, accuracy, linearity, range and limit of detection, limit of quantification, robustness, and device suitability testing are all covered by validation of HPLC methods according to ICH Guidelines.

Keywords: HPLC, Instrumentation, Method and Validation.