A REVIEW ON HPLC METHOD FOR THE ASSAY OF NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL IN NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP
Method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Analytical method validation is the process of demonstrating that an analytical method is reliable and adequate for its intended purpose. Any method that is utilized to determine results during drug substance and formulation development will have to be validated. Validation of HPLC methods focus mainly on the following. Identification Test. Quantitative measurements of the content of related substance. Semi quantitative and limit test for the control of related substances. Quantitative test for the assay of major components (Drug substances and Preservatives) in Samples of drug substance or drug product (assay, content uniformity, dissolution rate, etc.) Analytical method validation is established through documented evidence demonstrating the accuracy, precision, linearity, selectivity, ruggedness, and/or robustness of that particular test method which will be utilized to generate test results for a drug substance or drug product