Due to its very effective separations and often high detection sensitivity, HPLC is the most widely used separation method in contemporary pharmaceutical and biomedical analysis. The majority of medications in multiple component dosage forms can be examined using the HPLC method due to its many benefits, including speed, specificity, accuracy, precision, and ease of automation. The development and validation of HPLC procedures are crucial to novel discoveries, the creation of pharmaceutical medications, and numerous other investigations involving both humans and animals. To compare a defined characteristic of the drug substance or drug product to predetermined acceptance criteria for that characteristic, an analytical technique is designed. This review provides details on the numerous steps that go into developing and validating an HPLC technique. According to ICH Guidelines, validating an HPLC technique include testing for system appropriateness as well as accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness, and other performance characteristics.
HPLC, Method development, Validation
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