Abstract

A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

*Farheen A. Shah, Ashvini Y. Parbat, Manisha R. Chavhan, Dr. Manisha D. Kitukale, Dr. Anil V. Chandewar

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Abstract

Analytical method development and validation are the continual task connected with the research and development. The method development generally requires the collection of method specification and the decision of instrumentation. Analytical method is essential for a number of purposes including, testing of material and supply data to support specification. High performance liquid chromatography is most accurate method considerably used for the qualitative and quantitative analysis of the pharmaceutical medicine. Method validation is outlined as the method of proving that an analytical technique is suitable for the meant use and this is frequently an important condition for analytical purpose. Validation is used to decide reliability, consistency, and quality of analytical data. Validation parameters explain in terms of Accuracy, Linearity, Limit of detection, Limit of quantification, Ruggedness, Robustness. This review gives the consideration about several methods for pharmaceutical development and also gives various validation parameters as per the regulatory agency.

Keywords: Method development, Validation, High performance liquid chromatography, limit of detection, Limit of quantification, Robustness, Ruggedness.