Simultaneous liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and application

Abstract

A rapid and easy liquid chromatography-tandem mass spectrometry (LC–MS/MS) method was developed, validated, and used to quantify amlodipine besylate and metoprolol succinate in human plasma. Hydrochlorothiazide was used as the internal standard. LC–MS/MS with electrospray ionization in the positive ionization mode was performed under multiple reaction monitoring to examine analytes, which were drawn from human plasma via liquid–liquid extraction using a mixture of diethyl ether and dichloromethane (6:4). The extracts were dried under a nitrogen stream at 40°C, after which the samples were dissolved in a mixture of methanol and water (80:20). The re-dissolved samples were injected onto a C18 column and eluted using a mixture of methanol and 0.4% formic acid (80:20) as the mobile phase. Linear standard calibration was performed, and lower limits of quantification were determined for each analyte. The developedmethod was fully validated with respect to selectivity and carryover, as well as intra-and inter-day accuracy and precision in accordance with guidelines of the United StateFood and Drug Administration and the European Medicines Agency. Mean analyte recovery was between 71.72% and 97.55%, and matrix effects exerted only a minor influence on precision.The validated method was applied in aclinicalbioequivalence study to evaluate the in vivo bioequivalence of twocommer-cialproducts containing 5 mg amlodipine and 50 mg metoprolol. This randomized, single-dose, two-treatment, three-period, two-sequence, open-label, crossover study involved 14 healthy subjects, and a two-week washout period between the two phases of the research was implemented. Standard pharmacokinetic parameters were calculated to compare a test product with Selomax®as the reference. How to Cite this Article Pubmed Style Tuyen NTL, Nghiem LQ, Tuan ND. liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and application. SRP. 2019; 10(2): 1-7. doi:10.5530/srp.2019.2.01 Web Style Tuyen NTL, Nghiem LQ, Tuan ND. liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and application. http://www.sysrevpharm.org/?mno=302644896 [Access: March 31, 2021]. doi:10.5530/srp.2019.2.01 AMA (American Medical Association) Style Tuyen NTL, Nghiem LQ, Tuan ND. liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and application. SRP. 2019; 10(2): 1-7. doi:10.5530/srp.2019.2.01 Vancouver/ICMJE Style Tuyen NTL, Nghiem LQ, Tuan ND. liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and application. SRP. (2019), [cited March 31, 2021]; 10(2): 1-7. doi:10.5530/srp.2019.2.01 Harvard Style Tuyen, N. T. L., Nghiem, . L. Q. & Tuan, . N. D. (2019) liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and application. SRP, 10 (2), 1-7. doi:10.5530/srp.2019.2.01 Turabian Style Tuyen, Nguyen Thi Linh, Le Quan Nghiem, and Nguyen Duc Tuan. 2019. liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and Reviews in Pharmacy, 10 (2), 1-7. doi:10.5530/srp.2019.2.01 Chicago Style Tuyen, Nguyen Thi Linh, Le Quan Nghiem, and Nguyen Duc Tuan. Simultaneous liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and application. Systematic Reviews in Pharmacy 10 (2019), 1-7. doi:10.5530/srp.2019.2.01 MLA (The Modern Language Association) Style Tuyen, Nguyen Thi Linh, Le Quan Nghiem, and Nguyen Duc Tuan. Simultaneous liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and application. Systematic Reviews in Pharmacy 10.2 (2019), 1-7. Print. doi:10.5530/srp.2019.2.01 APA (American Psychological Association) Style Tuyen, N. T. L., Nghiem, . L. Q. & Tuan, . N. D. (2019) liquid chromatography-tandem mass spectrometry assay of amlodipine besylate and metoprolol succinate in human plasma: Development, validation, and Reviews in Pharmacy, 10 (2), 1-7. doi:10.5530/srp.2019.2.01