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KMID : 0369820150450030285
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Jorunal of Korean Pharmaceutical Sciences
2015 Volume.45 No. 3 p.285 ~ p.292
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Development and validation for the determination of olopatadine in human plasma by liquid chromatography?tandem mass spectrometry: application to a bioequivalence study of Ilhwa Allotadine tablet (olopatadine HCl 5 mg)
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Choi Soo-Wan
Ryu Ju-Hee
Park Ji-Sun
Lee Myung-Jae
Yim Sung-Vin
Lee Kyung-Tae
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Abstract
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A sensitive and specific method based on liquid chromatographic?tandem mass spectrometric method (LC?MS/MS) has been developed and validated to determine plasma concentrations of olopatadine. Olopatadine and internal standard (IS, loratadine) from human plasma were extracted using solid-phase extraction. Chromatographic separation was achieved on a reversed-phase Capcellpak CR column using the isocratic mobile phase consisted of 70 % acetonitrile and 30 % water containing 10 mM ammonium acetate (adjusted to pH 4.0 with acetic acid). Acquisition was performed in multiple reaction monitoring mode by monitoring the transitions: m/z 337.92 → 164.80 for olopatadine and m/z 383.17 → 336.90 for IS. This method was fully validated. The calibration curve was linear over the concentration range from 0.2 to 100 ng/mL, and correlation coefficients (r2) were greater than 0.99. The low limit of quantitation with a relative standard deviation below 20 % was 0.2 ng/mL. The intraday and interday precisions ranged 6.31?16.80 % and intraday and interday accuracies ranged 91.17?110.08 %. The devised method was successfully applied in a bioequivalence study of two formulations of olopatadine, Allotadine tablet and Allelock tablet in 26 healthy Korean volunteers following single oral administration.
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KEYWORD
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Olopatadine, Bioequivalence study, Liquid chromatography?tandem mass spectrometry, Method validation
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