The development and validation studies of RP-HPLC method – A review

Manasa Padma Meduri; Pooja Agarwal; G. Vimala; Nafiza Banu

Authors

Manasa Padma Meduri Department of Pharmaceutical Analysis, Geethanjali College of Pharmacy, Hyd. Telangana, India
Pooja Agarwal Department of Pharmaceutical Analysis, Geethanjali College of Pharmacy.
G. Vimala Department of Pharmaceutical Management and Regulatory Affairs, Geethanjali College of Pharmacy, Hyd. Telangana.
Nafiza Banu Department of Pharmacology, Geethanjali College of Pharmacy, Hyd. Telangana.

Keywords:

HPLC, method development, validation, related substances, force degradation

Abstract

Today there are many different strategies stating High Performance Liquid Chromatographic Method Development as well as RP-HPLC Technique^[8-9]. This review describes strategies for the systematic Development of High performance liquid chromatographic (HPLC) methods. HPLC is an analytical tool which is able to detect, separate and quantify the drug, and its various impurities and drug related degradants that can form on synthesis or storage. It involves the detection of the purity of a drug substance and facilitates in the development of its analytical method and also the various factors affecting them^[13]. A number of chromatographic parameters have been evaluated in order to optimize the methods in the analysis of method development in HPLC and RP-HPLC. An appropriate mobile phase, column, column temperature, wavelength and gradient are developed, suitability, compatibility and stability of drug as well as degradants and impurities should as well be evaluated appropriately. In analytical method development of a drug, drug along with its impurities can be quantified and interpreted ^[22]. Force degradation studies are helpful in development and validation of stability-indicating studies, determination of degradation pathways of drug substances and drug products, discernment of the degradation products in formulations that are related to drug substances versus those that are related to non–drug substances^[25] (e.g. related substances, excipients).