alexa Review on Analytical Method Development and Validation.
e-ISSN: 2320-0812 p-ISSN: 2347-2340

Research & Reviews: Journal of Pharmaceutical Analysis
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Review Article

Review on Analytical Method Development and Validation.

Rajendra Patil1*, Tushar Deshmukh1, Vijay Patil1, and Kishanchand Khandelwal2

1TVES’s Hon. Loksevak Madukarrao Chaudhari College of Pharmacy, Jalgaon - 425503, Maharashtra, India

2JSPM’s Rajarshi Shahu College of Pharmacy and Research, Pune - 411033, Maharashtra, India

*Corresponding Author:
Rajendra Patil
TVES’s Hon. Loksevak Madukarrao Chaudhari College of Pharmacy
Jalgaon - 425503, Maharashtra, India
Tel: + 91 9096697510

Received date: 22 April 2014 Accepted date: 21 May 2014

 

Abstract

Analytical methods development must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for quality control release, testing of stability samples, testing of reference materials and to provide data to support specifications.Analytical method followed by process of establishing evidence that provides a high degree of assurance and 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. This review gives ideas about various methods to check the stability of drug and various validation parameters as per various regulatory authorities.

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