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- Title
HPLC method development and validation- an overview.
- Authors
Singh, Ranjit
- Abstract
HPLC method development and validation play important role in the discovery, development and manufacture of pharmaceutical products. This article mainly focuses on the optimization of HPLC conditions and other important perspectives during method development and validation. Various critical steps related to analytical method development and validation is discussed. A sequence of events required for method development and analytical validation are described. The steps involved in developing a stability-indicating HPLC method influences the analysis of degradation products/impurities in stability study and its validation demonstrate the suitability for its intended purpose.
- Subjects
HIGH performance liquid chromatography; DRUG development; PHARMACEUTICAL industry; DRUG carriers; DRUG synthesis; MEDICINE
- Publication
Journal of Pharmaceutical Education & Research, 2013, Vol 4, Issue 1, p26
- ISSN
0976-8173
- Publication type
Article