LC-MS/MS method for determination of megestrol in human plasma and its application in bioequivalence study.
10.1007/s11596-013-1221-9
- Author:
Fan LI
1
;
Xiao-juan ZOU
;
Heng ZHENG
;
Yi XIANG
Author Information
1. College of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China, bingfanning@163.com.
- Publication Type:Journal Article
- MeSH:
Calibration;
Gas Chromatography-Mass Spectrometry;
methods;
standards;
Humans;
Megestrol;
blood;
chemistry;
pharmacokinetics;
Therapeutic Equivalency
- From:
Journal of Huazhong University of Science and Technology (Medical Sciences)
2013;33(6):912-916
- CountryChina
- Language:English
-
Abstract:
A rapid and highly selective liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for the determination of megestrol in human plasma was described using medrysone as internal standard (IS). Blood samples were collected from 20 healthy volunteers after oral administration of 160 mg megestrol acetate dispersible tablets. The analytes were extracted by liquid-liquid extraction procedure and separated on a hanbon lichrospher column with the mobile phase of methanol and water containing 0.1% formic acid and 20 mmol/L ammonium acetate (5:1, v/v). Positive ion electrospray ionization with multiple reaction-monitoring mode (MRM) was employed by monitoring the transitions m/z 385.5-325.4 and m/z 387.5-327.4 for megestrol and medrysone, respectively. Under the isocratic separation conditions, the chromatographic run time was approximately 2.54 min for megestrol and 2.59 min for medrysone. The calibration curve range was from 0.5 to 200.0 ng/mL. The inter-batch and intra-batch precision and accuracy were less than 5.2% relative standard deviation (RSD) and 6.4% relative error (RE). The proposed method was successfully applied in the bioequivalence study of megestrol acetate dispersible tablets.
