European Journal of Biomedical and Pharmaceutical Sciences

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC AND UV SPECTROPHOTOMETRIC METHODS

Ashwini B. Sambherao*, Bhushan A. Bhairav and Dr. R. B. Saudagar

ABSTRACT

Analytical methods development must be validated to provide reliable data for regulatory submissions. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. High Performance Liquid Chromatography (HPLC) and UV Visible Spectrophotometry are an essential analytical tool in assessing drug product. These methods are essential for a number of purposes, including testing for quality control release, testing of stability sample, testing of reference materials and to degree of assurance and is an important process in the drug discovery. Although the drug shows good potency, lack of validated analytical method will not allow the drug to enter into the market. This is to ensure the quality and safety of the drug. This review gives ideas about various methods to check the stability of dug and various validation parameters as per various regulatory authorities.

Keywords: Method Development, UV, RP-HPLC, validation.