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KMID : 0369819910210030179
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Jorunal of Korean Pharmaceutical Sciences
1991 Volume.21 No. 3 p.179 ~ p.188
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Validation Process of HPLC Assay Methods of Drugs in Biological Samples
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지상철/Chi SC
전흥원/Jun HW
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Abstract
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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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KEYWORD
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HPLC, validation, biological sample, verapamil
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FullTexts / Linksout information
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Listed journal information
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