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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMCITABINE: A REVIEW
Analytical method development and validation is an integral part during the development of drug substance and drug product in the pharmaceutical industry. It plays important role in the discovery, development, manufacture and quality control of pharmaceuticals. Analytical methods are designed to determine the drug content in formulation, presence of impurities, separation of drug and its related impurities and degraded products. Validation of method proves that it can be suitable for its use in research and development and assures the reliability of proposed method. Now days, need of analytical method development is increasing due to the emergence of new drugs and development of new combinations of various drugs as their standard methods are not available in Pharmacopoeias. An effective method development and its validation prove to be very useful in drug discovery and development. This review is focused on literature findings from 2014-2018 of analytical method development and validation of gemcitabine hydrochloride drug in various dosage forms. Keywords: Gemcitabine, method development, spectrophotometric, RP-HPLC, validation.
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMCITABINE: A REVIEW
Analytical method development and validation is an integral part during the development of drug substance and drug product in the pharmaceutical industry. It plays important role in the discovery, development, manufacture and quality control of pharmaceuticals. Analytical methods are designed to determine the drug content in formulation, presence of impurities, separation of drug and its related impurities and degraded products. Validation of method proves that it can be suitable for its use in research and development and assures the reliability of proposed method. Now days, need of analytical method development is increasing due to the emergence of new drugs and development of new combinations of various drugs as their standard methods are not available in Pharmacopoeias. An effective method development and its validation prove to be very useful in drug discovery and development. This review is focused on literature findings from 2014-2018 of analytical method development and validation of gemcitabine hydrochloride drug in various dosage forms. Keywords: Gemcitabine, method development, spectrophotometric, RP-HPLC, validation.
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMCITABINE: A REVIEW
Pawanpreet Kaur* and Baljeet Singh (author)
2018-06-11
oai:zenodo.org:1286729
INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05(06) 5065-5070
Article (Journal)
Electronic Resource
English
DDC:
690
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