DEVELOPMENT AND VALIDATION BY HPLC METHOD

Overview & Synopsis

Validation of an analytical procedure is the process of demonstrate with suitable for itsintended purpose. Chromatographic such HPLC methods play significant role in thepharmaceutical industry from the drug discovery, development of drugs, formulations andquality control of chemicals. Many validated analytical methods ensure that it providesconsistent, reliable and accurate data for results. So these methods help pharmaceuticalanalyst to ensure quality products are released for market. This review explains generalapproach for validation process and validation parameters to be considered during validationof a HPLC method. It also used to refer for various regulatory requirements. The parametersdescribed follow to ICH guidelines and include accuracy, precision, specificity and limit ofdetection, limit of quantitation, linearity, range and robustness.