Journal of Pharmaceutical Investigation
- Volume 21 Issue 3
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- Pages.179-188
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- 1991
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- 2093-5552(pISSN)
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- 2093-6214(eISSN)
Validation Process of HPLC Assay Methods of Drugs in Biological Samples
생체시료내 약물의 HPLC 분석법에 대한 유효성 검토방법
- Chi, Sang-Cheol (Department of Pharmaceutics, Sung Kyun Kwan University) ;
- Jun, H.-Won (Department of Pharmaceutics, University of Georgia)
- Published : 1991.09.20
Abstract
An HPLC assay method of a drug to be applied to the pharmacokinetic studies of the drug should be completely validated. The validation process for an HPLC assay method in a biological sample was discussed using the data obtained from the development of HPLC method for the simultaneous quantitation of verapamil and norverapamil in human serum. The validation criteria included were specificity, linearity, accuracy, precision, sensitivity, recovery, drug stability, and ruggedness of an assay method.