The development and validation studies of RP-HPLC method – A review
Journal Title: World Journal of Pharmaceutical Sciences - Year 2016, Vol 4, Issue 1
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).
Authors and Affiliations
Manasa Padma M
Keywords
Related Articles
- EP ID EP194782
- DOI -
- Views 128
- Downloads 0
Stability evaluation of Phyllanthus Urinaria extract loaded palm kernel oil esters-based nanoemulsions
Storage stability evaluation of Phyllanthus urinaria extract loaded palm kernel oil esters-based nanoemulsion creams was carried at various environmental conditions for duration of three months. The formulations were eva...
Constituents from the Leaves of Tecoma stans Juss
Tecoma stans Juss (Bignoniaceae) has wide range of therapeutic uses and is used in the treatment of diabetes, digestive problems, infections, diuretic and vermifuge. In an attempt to isolate the phytoconstituents from th...
Pharmacognostical Studies of Azima Tetracantha Lam. (Salvadoraceae)
The present study deals with evaluation of pharmacognostical characters of an important medicinal plant, Azima tetracantha Lam. The pharmacognostical studies were carried out such as organoleptic, macroscopic, microscopi...
Variation in the essential oil of Origanum vulgare (L) growing at different geographical locales of Kashmir Himalayas, India
The agro climatic conditions of Kashmir valley provide an ideal habitat for the growth of variety of aromatic and medicinal plant species. The present study was conducted to analyse the essential oils obtained from Origa...
Galantamine as benzofuro-benzazepine alkaloid used in cognition and dementia
Galantamine is used to treat the symptoms of Alzheimer's disease (AD; a brain disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities). Galantamine is in a class o...