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Sci. Pharm. 2010, 78(3), 411-422; doi:10.3797/scipharm.1002-07

Method Development and Validation of Montelukast in Human Plasma by HPLC Coupled with ESI-MS/MS: Application to a Bioequivalence Study

1
Jawaharlal Nehru Technological University, Anantapur, Andhra Pradesh, 515002, India
2
Siddharth Institute of Pharmacy, Nalanda Educational Society, Kantepudi, Sattenapalli, Guntur, 522438, India
3
Faculty of Pharmacy, Al-Jabal Al-Gharbi University, Libya
4
Jawaharlal Nehru Technological University, Hyderabad, 500072, India
*
Author to whom correspondence should be addressed.
Received: 10 February 2010 / Accepted: 4 June 2010 / Published: 4 June 2010
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Abstract

A simple, sensitive, and specific LC-ESI–MS/MS method for quantification of Montelukast (MO) in human plasma using Montelukast-d6 (MOD6) as an internal standard (IS) is discussed here. Chromatographic separation was performed on YMC-pack pro C18, 50 x 4.6 mm, S-3 μm 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−1. MO and MOD6 were detected with proton adducts at m/z 586.2→568.2 and 592.3→574.2 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 1.0–800.0 ng mL−1 with correlation coefficient (r2) ≥ 0.9996. The intraday precision and accuracy were within 1.91–7.10 and 98.32–99.17. The inter-day precision and accuracy were within 3.42–4.41% and 98.14–99.27% 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.
Keywords: Montelukast; LC-ESI-MS/MS; Bioequivalence study Montelukast; LC-ESI-MS/MS; Bioequivalence study
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

CHALLA, B.R.; AWEN, B.Z.; CHANDU, B.R.; KHAGGA, M.; KOTTHAPALLI, C.B. Method Development and Validation of Montelukast in Human Plasma by HPLC Coupled with ESI-MS/MS: Application to a Bioequivalence Study. Sci. Pharm. 2010, 78, 411-422.

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