Journal of Pharmaceutical Investigation
- 제21권3호
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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)
생체시료내 약물의 HPLC 분석법에 대한 유효성 검토방법
Validation Process of HPLC Assay Methods of Drugs in Biological Samples
- Chi, Sang-Cheol (Department of Pharmaceutics, Sung Kyun Kwan University) ;
- Jun, H.-Won (Department of Pharmaceutics, University of Georgia)
- 발행 : 1991.09.20
초록
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.