Journal of Advanced Pharmacy Education & Research
Year : 2012   |  Volume : 2   |  Issue : 3   |  Page : 146-176  

Method Development and Validation- A Review

Sudha T., Krishana Kanth V., Nukala Poorana Chandra Sainath, Mishal, Saloman Raja T, Ganesan V

Correspondence Address:1. Department of Pharmaceutical Analysis, The Erode College of Pharmacy & Research, Erode, India 2. Department of Pharmaceutics, The Erode College of Pharmacy & Research, Erode, India

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2231-4040.197331


Analytical method development followed by method validation 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. The main objective of this review is to give an idea about the old and novel techniques available for the analysis of drugs in their raw material and formulated forms, check the stability of the drugs in the presence of the excipients and other stress conditions experienced during their shelf life period. The review work puts a light on the hyphenated techniques for the analysis and impurity profiling of drugs like LC-MS-MS, LCNMR-MS, GC-MS and LC –MS. This review also deals with the bioanalytical method development for the quantitative determination of the drugs in the various biological matrices. It also provides a means to determine the biological safety of the drugs by dealing with the SIAMs (stability indicating assay methods).

Keywords: Validation, Stability indicating, Impurity, bioanalytical, HPLC, HPTLC.

How to cite this article:

Introduction   Top

Materials and methods   Top

Results Discussion   Top

Conclusion   Top

Acknowledgement   Top

References   Top