<?xml version="1.0" encoding="UTF-8"?><Articles><Article><id>652</id><JournalTitle>A REVIEW ON HPLC METHOD FOR THE ASSAY OF NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL IN NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP</JournalTitle><Abstract>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</Abstract><Email>sunilgarje13@gmail.com</Email><articletype>Review</articletype><volume>6</volume><issue>8</issue><year>2015</year><keyword>High Performance Liquid Chromatography,Good Manufacturing Practice,International Conference on Harmonization</keyword><AUTHORS>Rajveer Bhaskar,Monika Ola, P. H. Patil,Sunil Garje</AUTHORS><afflication>R. C. Patel institute of Pharmaceutical Education and Research Centre, Shirpur, Dhule, Maharashtra, India.,R. C. Patel institute of Pharmaceutical Education and Research Centre, Shirpur, Dhule, Maharashtra, India.,R. C. Patel institute of Pharmaceutical Education and Research Centre, Shirpur, Dhule, Maharashtra, India.,R. C. Patel institute of Pharmaceutical Education and Research Centre, Shirpur, Dhule, Maharashtra, India.</afflication></Article></Articles>