Bioanalytical Method Development and Validation of Stabiliity Indicating Lc-Ms/Ms Method to Determine Montelucast in Human Plasma
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Keywords
Montelucast, liquid chromatography, MS/MS, Montelucast D6 sodium salt
Abstract
Objective: A rapid and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method was developed and fully validated for the determination of Montelucast in human plasma.
Materials and Methods: Montelucast D6 Sodium salt was used as an internal standard (IS). Analytes and the internal standard were extracted from human plasma by solid-phase extraction technique using Oasis HLB, Oasis Max, Varian Bond Elute Plexa, Orochem cartridges. The reconstituted samples were chromatographed on a ZORBAX Eclipse XDB Phenyl (4.6 X 75 mm, 3.5μ) by using Acetonitrile: 5mM Ammonium acetate buffer (85:15 v/v) as the mobile phase at a flow rate of 1.0 mL/min.
Results and Discussion: Detection was carried out LC-MS/MS (API 3000) in negative ion mode. The calibration curves obtained were linear (R2-0.999) over the concentration range of 5.032 - 602.362 ng/mL for Montelucast.. The results of the intra- and inter-day precision studies were well within the acceptable limits. The mean overall recovery of Montelukast was 58.56% with a precision ranging from 1.00% to 5.17%. The mean recovery of internal standard Montelukast D6 was 57.75% with a precision ranging from 4.25% to 5.08%.No statistical outlier was found.
Conclusion: The analyte were found to be stable of stability study. Developed and validated analytical method was found to be simple, rapid, specific, sensitive, precise and cost effective than reported methods. The method has been successfully applied to the investigation of a preclinical pharmacokinetic study with desired precision and accuracy along with high throughput.
References
2. Lu CY, Zhang F, Lakoma MD, Butler MG, Fung V, Larkin EK, Kharbanda EO, Vollmer WM, Lieu T, Soumerai SB, Chen Wu A: Asthma Treatments and Mental Health Visits After a Food and Drug Administration Label Change for
Leukotriene Inhibitors. Clin Ther. 2015 Jun 1;37(6):1280-91
3. Singulair (montelukast sodium) US FDA Label 2019
4. Apo-Montelukast Canadian Product Monograph
5. Leff JA, Busse WW, Pearlman D, Bronsky EA, Kemp J, Hendeles L, Dockhorn R, Kundu S, Zhang J, Seidenberg BC, Reiss TF. New England Journal of Medicine. 1998 Jul 16;339(3):147-52.
6. Noonan MJ, Chervinsky P, Brandon M, Zhang J, Kundu S, McBurney J, Reiss TF. European Respiratory Journal. 1998 Jun 1;11(6):1232-9.
7. Leff JA, Busse WW, Pearlman D, Bronsky EA, Kemp J, Hendeles L, Dockhorn R, Kundu S, Zhang J, Seidenberg BC, Reiss TF. New England Journal of Medicine. 1998 Jul 16;339(3):147-52.
8. Kemp JP, Dockhorn RJ, Shapiro GG, Nguyen HH, Reiss TF, Seidenberg BC, Knorr B. The Journal of pediatrics. 1998 Sep 30;133(3):424-8.
9. Jones TR, Labelle M, Belley M, Champion E, Charette L, Evans J, Ford-Hutchinson AW, Gauthier JY, Lord A, Masson P, McAuliffe M. Canadian journal of physiology and pharmacology. 1995 Feb 1;73(2):191-201.
10. Filppula AM, Laitila J, Neuvonen PJ, Backman JT. Drug Metabolism and Disposition. 2011 May 1;39(5):904- 11.
11. http://www.drugs.com/pro/singulair.htmlaccessed on 5-Nov-2015. [8] Vaidya, VV.; Singh, G. R.; Kekare, M. B.; Choukekar, M. P Anal.Chem. 7 (8), 598-601, 2008.
12. Sripalakit, P.; Kongthong, B.; Saraphanchotiwitthaya, A. A simple bioanalytical assay for determination of Montelukast in human plasma: Application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2008
13. Sripalakit, P.; Kongthong, B.; Saraphanchotiwitthaya, A. A simple bioanalytical assay for determination of Montelukast in human plasma: Application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2008
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