| DOI: https://doi.org/10.14456/mujps.2016.2 | Pharm Sci Asia 2016; 43(1), 17-27 |
A LCMS-IT-TOF method for the quantification of tamsulosin in human plasma and application to a bioequivalence study in healthy Vietnamese volunteersG.T.H. Nguyen*, D.H.N. Huynh, K.H.L. Nguyen, H.T.T. Tran, V.N. Nguyen
- Institute of Drug Quality Control - Ho Chi Minh City, 200 Cobac Street, District 1, Ho Chi Minh City, Vietnam
Tamsulosin hydrochloride is an alpha1 adreno receptor blocking agent used for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. A highly sensitive, rapid and accurate LCMS-IT-TOF method was developed for determination of tamsulosin in human plasma. Analyte and internal standard were separated on Gemini C18 (150 mm x 4.6 mm, 5 μm particle size) column with a mobile phase of methanol and 5 % formic acid buffer in a ratio of 50:50 (v/v). The method had a chromatography run time of 4 min and was linear in the concentration range of 0.5-50 ng/mL; the intra-day and inter-day accuracy (bias ≤ 9.8 %) and precision (CV ≤ 5.4 %) . The limit of quantitation was 0.5 ng/mL. This method was employed in bioequivalence study of tamsulosin. A bioequivalence study of two modified release formulations of tamsulosin hydrochloride 0.4 mg in healthy Vietnamese male populations was conducted (Tamsustad of STADA-VN Joint Venture Co., Ltd., Vietnam, as test product; FLOMAX relief®MR of Boehringer Ingelheim Limited, United Kingdom, as reference product). After dosing, serial blood samples were collected for a period of 96 hrs. No clinically significant or serious adverse events were observed during the study. The 90% confidence intervals for the ratios of Cmax, AUC0-t and AUC0-∞ suggested that a single dose of the test and reference modified-release formulations of tamsulosin hydrochloride met the FDA regulatory requirements of bioequivalence definition intervals of 80.00% - 125.00%.
Keyword:
LCMS-IT-TOF, Tamsulosin, Bioeqivalence
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