A rapid and simple UPLC-MS-MS method for determination of glipizide in human plasma and its application to bioequivalence study.
In this study, a simple, rapid and sensitive ultra performance liquid chromatography-tandem mass spectrometry method is described for the determination of glipizide in human plasma samples using carbamazepine as the internal standard (IS) from bioequivalence assays. Sample preparation was accomplished through protein precipitation with methanol, and chromatographic separation was performed on an Acquity BEH C18 column (2.1 mm × 50 mm, 1.7 μm) with gradient profile at a flow rate of 0.4 mL/min. Mass spectrometric analysis was performed using an QTrap5500 mass spectrometer coupled with an electrospray ionization source in the positive ion mode. The multiple reaction monitoring transitions of m/z 446.1 → 321.0 and m/z 237.1 → 194.2 were used to quantify for glipizide and IS. The linearity of this method was found to be within the concentration range of 10-1,500 ng/mL for glipizide in human plasma. Only 1.0 min was needed for an analytical run. The method was applied to a bioequivalence study of two drug products containing glipizide in human plasma samples.
Medical College of Henan University of Science and Technology, Luoyang 471003, China.
Xiangjun
X
Qiu
The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China.
Shuang-li
SL
Zheng
Medical College of Henan University of Science and Technology, Luoyang 471003, China.
Yingfei
Y
Wang
Medical College of Henan University of Science and Technology, Luoyang 471003, China.
Rong
R
Wang
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China yelei2014@163.com.
Lei
L
Ye
D000328:Adult; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D005913:Glipizide / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D007004:Hypoglycemic Agents / Q000097:blood* / Q000493:pharmacokinetics; D008297:Male; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
D007004:Hypoglycemic Agents; D005913:Glipizide