METHOD DEVELOPMENT AND VALIDATION ANALYTICAL TECHNIQUES: AN UPDATED REVIEW
Saurav A. Shahu*, Pratik R. Lanje, Monika R. Uikey and Priya V. Borker
ABSTRACT
The main objective of this review is analytical techniques utilized in method development and validation. Because it is extremely much significant for the steadiness, efficacy and quality of the drug product. Various novel analytical techniques like, LC-MS, RP-HPLC Automated development in HPTLC, LC-MS-MS are discussed during this review with suitable samples of drugs concerning ICH Guidelines. Various Validation parameters like Accuracy, Specificity, Precision, Linearity, LOD, LOQ, Ruggedness, and Robustness also are listed concerning ICH Guidelines. Validation is extremely much useful for the standard Control and Quality Assurance of Pharmaceuticals and therefore the safety of patients.[1]
Keywords: Analytical method development, validation parameters, acceptance criteria.
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