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KMID : 0369820080380020135
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 2 p.135 ~ p.142
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Bioequivalence of Atorva to Lipitor (Atorvastatin 20 mg)
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Lim Hyon-Kyun
Lee Tae-Ho
Lee Jae-Hyun
Youm Jeong-Rok
Song Jin-Ho
Han Sang-Beom
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Abstract
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The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor (Pfizer, reference drug) and Atorva (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. (maximum plasma drug concentration) and (time to reach ) were complied trom the plasma concentration-time data. Analysis of variance wa s carried out using logarithmically transformed and . No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the ratio and the ratio for Atorva / Lipitor were and , respectively. These values were within the acceptable bioequivalence intervals of . Based on these statistical considerations, it was concluded that the test drug, Atorva was bioequivalent to the reference drug, Lipitor .
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KEYWORD
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Atorvastatin, Bioequivalence, LC-MS/MS, Analytical Validation
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