STABILITY INDICATING HPLC METHOD DEVELOPMENT – A REVIEW
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 5
Abstract
High performance liquid chromatography (HPLC) is an essential analytical tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants that can form on storage or manufacturing, plus detect and quantify any drug-related impurities that may be introduced during synthesis. This article discusses the strategies and the issues pertinent to designing stability-indicating HPLC methods for drug substances. It furthers understanding of the chemistry of the drug substance and drug product and facilitates the development of stability indicating analytical methodology. A number of key chromatographic factors were evaluated in order to optimize the detection of all potentially relevant degradants. An appropriate sample solvent and mobile phase must be found that affords suitable stability and compatibility with the component of interest as well as the potential impurities and degradants. The method should be carefully examined for its ability to distinguish primary degradants from secondary degradants. Forced degradation studies of new chemical entities and drug products are essential to help develop and demonstrate the specificity of such stability-indicating methods. Practical recommendations are provided for developing forced degradation protocols at every stage of drug development and avoiding common pitfalls that may confuse data interpretation.
Authors and Affiliations
Riddhiben Patel , Piyushbhai Patel , Natubhai Patel
Keywords
Related Articles
- EP ID EP134987
- DOI -
- Views 101
- Downloads 0
CURD: A SEDATIVE WITH A BONUS BOWL OF USEFUL SIDE EFFECTS
A daily bowl of fresh curd/yogurt helps in preventing numerous diseases. Curd/yoghurt may be viewed as a natural healing food supplement. It has a perfect balance of proteins, carbohydrates, fats, minerals and vitamins....
SENSORY AND NUTRITIONAL QUALITY OF SOY FORTIFIED TRADITIONAL PRODUCT
Cereals and pulses are the main constituents of any food all over the world. Cereals are considered as a major source of energy but they content less protein than animal protein. Soybean is one of the pulses that contain...
GREEN CHEMISTRY POTENTIAL FOR PAST, PRESENT AND FUTURE PERSPECTIVES
Chemistry brought about medical revolution till about the middle of twentieth century in which drugs and antibiotics were discovered. The world’s food supply also increased enormously due to the discovery of hybrid varie...
PHYTOCHEMICAL INVESTIGATION OF THE SILK COCOONS OF BOMBYX MORI L.
Silk cocoons, produced by Bombyx mori L. (Bombicidae) are useful as hypotensive, expectorant, bronchodilator and attenuant drug in traditional medicine. Phytochemical investigation of the ethanolic extract of the cocoons...
DEVELOPMENT AND CHARACTERIZATION OF PREDNISOLONE LIPOSOMAL GEL FOR THE TREATMENT OF RHEUMATOID ARTHRITIS
The present objective for the study was to prepare prednisolone liposomal gel intended for topical application. Various liposome formulations were prepared using Vortexing Sonication technique using vacuum rotator evapor...