生物等效性和生物利用度杂志

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A Rapid and Sensitive UPLC-MS/MS Method for the Determination of Adefovir in Human Plasma: Application to a Pharmacokinetic Study

Nasr AA, Abo-Aly MM, Makram TS and Alzoubi MI

A sensitive, rapid and selective liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) analytical method based on protein precipitation was developed and validated for analysis of Adefovir in human plasma. Adefovir-d4 was used as an internal standard and Waters X-Select HSS T3-C18 (3.0 × 50 mm, 2.5 μm) column provided the desired chromatographic separation of compounds followed by detection with mass spectrometry. The method used simple isocratic chromatographic condition and mass spectrometric detection in the positive ionization mode. The calibration curves were linear over the range of 1.00 ng/mL to 30.00 ng/mL with the lower limit of quantitation validated at 1.00 ng/mL. The degree of matrix effect for Adefovir was determined in six different sources of human plasma was 5.23% and had no impact on study samples analysis with the shortest runtime obtained (1.5 min). The intra- and inter-day precision values were within 2.37% and 7.87%, respectively, for Adefovir at the lower limit of quantification level. The method described here was successfully applied for the evaluation of pharmacokinetic profiles of Adefovir after single oral administration doses of 10 mg Adefovir dipivoxil to 28 healthy volunteers.