Sensitive LC-MS/MS Method for the Simultaneous Determination of Bisoprolol and Triamterene in human plasma


Hemavathi G, Hipparagi S M

Abstract


Objective: A highly sensitive, specific, and rapid liquid chromatography-electrospray ionization-mass spectrometry (MS)/MS method has been developed and validated for the simultaneous quantification of bisoprolol and triamterene in human plasma using metoprolol as an internal standard (IS) as per regulatory guidelines.

Methods: Both the analytes and IS were extracted from plasma using a protein precipitation extraction method. Chromatography was achieved on Welchrom XB C18, 50 mm×4.6 mm, 5 µm column using an isocratic mobile phase (2 mM ammonium formate acetonitrile, 70:30 v/v) at a flow rate of 0.60 ml/minute.

Results: The total chromatographic run time was 3.5 minute and the elution of bisoprolol, triamterene, and IS occurred at ~2.57, 1.30 and 1.57 minute, respectively. A linear response function was established at 2.04-210 ng/ml for both the analytes in human plasma. The intra- and inter-day accuracy and precisions were in the range of 1.12-7.87 and 1.26-6.36%; 1.46-6.13 and 1.65-7.34% for bisoprolol and triamterene, respectively.

Conclusion: A new robust method was developed for simultaneous determination of Bisoprolol and Triamterene in human plasma. The method was strictly validated according to the ICH [1] guidelines. The information thus obtained from the study can be used for the full pharmacokinetic profiling in individuals.

Keywords: Bisoprolol, Triamterene, Liquid chromatography-mass spectrometry/mass spectrometry, Method validation, Human plasma,
Pharmacokinetics.


| PDF |

References


Ding L, Zhou X, Guo X, Song Q, He J, Xu G. LC-ESI-MS method for the determination of bisoprolol in human plasma. J Pharm Biomed Anal 2007;44(2):520-5.

Bhatt J, Subbaiah G, Kambli S, Shah B, Patel M, Saxena A, et al. A high throughput and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the estimation of bisoprolol in human plasma using multiplexing technique. J Chromatogr B Analyt Technol Biomed Life Sci 2007;852(1-2):374-81.

US DHHS, FDA, CDER, CVM. Guidance for Industry: Bioanalytical Method Validation. Rockville, MD, USA: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM); 2001.

Liu GY, Wang W, Jia JY, Lu C, Liu YM, Zhang MQ, et al. Liquid chromatography tandem mass spectrometry method for determination of bisoprolol in human plasma using d5-bisoprolol as the internal standard. Biomed Chromatogr 2010;24(6):574-80.

Yadav SS, Rao JR. Simultaneous HPTLC analysis of bisoprolol fumarate and hydrochlorthiazide in pharmaceutical dosage form. Int J Pharm Pharm Sci 2013;2:286.

Iram M, Shobha Rani RH. Estimation of metoprolol in human plasma by hplc method. Int J Pharm Pharma Sci 2015;1:442.

Hsu KF, Chien KY, Chang-Chien GP, Lin SF, Hsu PH, Hsu MC. Liquid chromatography-tandem mass spectrometry screening method for the simultaneous detection of stimulants and diuretics in urine. J Anal Toxicol 2011;35(9):665-74.

Bonfiglio R, King RC, Olah TV, Merkle K. The effects of sample preparation methods on the variability of the electrospray ionization response for model drug compounds. Rapid Commun Mass Spectrom 1999;13(12):1175-85.




About this article

Title

Sensitive LC-MS/MS Method for the Simultaneous Determination of Bisoprolol and Triamterene in human plasma

DOI

10.22159/ajpcr.2017.v10i4.16829

Date

01-04-2017

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 10 Issue 4 April 2017 Page: 477-484

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

161 Views | 5 Downloads

Authors & Affiliations

Hemavathi G
KLE's College of Pharmacy. Bangalore
India

Hipparagi S M
KLE's College of Pharmacy. Bangalore
India


Article Tools


Email this article (Login required)
Email the author (Login required)

Refbacks

  • There are currently no refbacks.