|
A LCMS-IT-TOF method for the quantification of tamsulosin in human plasma and application to a bioequivalence study in healthy Vietnamese volunteers |
|---|---|
| รหัสดีโอไอ | |
| Creator | 1. G.T.H. Nguyen 2. D.H.N. Huynh 3. K.H.L. Nguyen 4. H.T.T. Tran 5. V.N. Nguyen |
| Title | A LCMS-IT-TOF method for the quantification of tamsulosin in human plasma and application to a bioequivalence study in healthy Vietnamese volunteers |
| Publisher | Faculty of Pharmacy, Mahidol University |
| Publication Year | 2559 |
| Journal Title | Mahidol University Journal of Pharmaceutical Sciences |
| Journal Vol. | 43 |
| Journal No. | 1 |
| Page no. | 17-27 |
| Keyword | LCMS-IT-TOF, Tamsulosin, Bioeqivalence |
| Abstract | 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 _m 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 ฒ 9.8 %) and precision (CV ฒ 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 reliefจMR 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-ฐ 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%. |
