Method Development and Validation of Montelukast in Human Plasma by HPLC Coupled with ESI-MS/MS: Application to a Bioequivalence Study
| Autor: | Mukkanti Khagga, Babu Rao Chandu, Chandrasekhar Bannoth Kotthapalli, Bahlul Z. Awen, Balasekhara Reddy Challa |
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| Rok vydání: | 2010 |
| Předmět: |
Accuracy and precision
Analyte Chromatography Correlation coefficient Chemistry Electrospray ionization Selected reaction monitoring Pharmaceutical Science LC-ESI-MS/MS Original Papers High-performance liquid chromatography chemistry.chemical_compound Bioequivalence study Ammonium formate Acetonitrile Research Article Montelukast |
| Zdroj: | Scientia Pharmaceutica Volume 78 Issue 3 Pages 411-422 |
| ISSN: | 2218-0532 0036-8709 |
| DOI: | 10.3797/scipharm.1002-07 |
| Popis: | A simple, sensitive, and specific LC-ESIâMS/MS method for quantification of Montelukast (MO) in human plasma using Montelukast-d(6) (MOD6) as an internal standard (IS) is discussed here. Chromatographic separation was performed on YMC-pack pro C(18), 50 x 4.6 mm, S-3 Îm column with an isocratic mobile phase composed of 10mM ammonium formate (pH 4.0):acetonitrile (20:80 v/v), at a flow-rate of 0.8 mL min(â1). MO and MOD6 were detected with proton adducts at m/z 586.2â568.2 and 592.3â574.2 in multiple reaction monitoring (MRM) positive mode respectively. MO and MOD6 were extracted using acetonitrile as precipitating agent. The method was validated over a linear concentration range of 1.0â800.0 ng mL(â1) with correlation coefficient (r(2)) â 0.9996. The intraday precision and accuracy were within 1.91â7.10 and 98.32â99.17. The inter-day precision and accuracy were within 3.42â4.41% and 98.14â99.27% for MO. Both analytes were found to be stable throughout three freeze-thawing cycles, bench top, and autosampler stability studies. This method was utilized successfully for the analysis of plasma samples following oral administration of MO (5 mg) in 31 healthy Indian male human volunteers under fasting conditions. |
| Databáze: | OpenAIRE |
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