Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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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)
  • 지상철 (성균관대학교 약학대학) ;
  • 전흥원 (미국 Georgia 대학교 약학대학)
  • Published : 1991.09.20
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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.

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