一种用于生物样品中硫酸特布他林测定的验证型 HPTLC 方法：在药代动力学研究中的应用。
A validated HPTLC method for determination of terbutaline sulfate in biological samples: Application to pharmacokinetic study.
机构信息
Formulation Research Laboratory, Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, Hamdard Nagar, New Delhi 110 062, India ; Faculty of Pharmacy, Integral University, Dasauli, Kursi Road, Lucknow 222 026, Uttar Pradesh, India.
出版信息
Saudi Pharm J. 2011 Jul;19(3):185-91. doi: 10.1016/j.jsps.2011.03.004. Epub 2011 Apr 1.
Terbutaline sulfate (TBS) was assayed in biological samples by validated HPTLC method. Densitometric analysis of TBS was carried out at 366 nm on precoated TLC aluminum plates with silica gel 60F254 as a stationary phase and chloroform-methanol (9.0:1.0, v/v) as a mobile phase. TBS was well resolved at RF 0.34 ± 0.02. In all matrices, the calibration curve appeared linear (r (2) ⩾ 0.9943) in the tested range of 100-1000 ng spot(-1) with a limit of quantification of 18.35 ng spot(-1). Drug recovery from biological fluids averaged ⩾95.92%. In both matrices, rapid degradation of drug favored and the T 0.5 of drug ranged from 9.92 to 12.41 h at 4 °C and from 6.31 to 9.13 h at 20 °C. Frozen at -20 °C, this drug was stable for at least 2 months (without losses >10%). The maximum plasma concentration (Cpmax) was found to be 5875.03 ± 114 ng mL(-1), which is significantly higher than the maximum saliva concentration (Csmax, 1501.69 ± 96 ng mL(-1)). Therefore, the validated method could be used to carry out pharmacokinetic studies of the TBS from novel drug delivery systems.
硫酸特布他林（TBS）采用经过验证的 HPTLC 方法在生物样品中进行测定。TBS 的密度分析在预涂有硅胶 60F254 的 TLC 铝板上于 366nm 进行，以氯仿-甲醇（9.0:1.0，v/v）为流动相。TBS 在 RF 0.34±0.02 处得到很好的分离。在所有基质中，校准曲线在 100-1000ng 点-1 的测试范围内呈线性（r (2) ⩾0.9943），定量下限为 18.35ng 点-1。从生物流体中药物的回收率平均 ⩾95.92%。在这两种基质中，药物迅速降解，药物的 T 0.5 在 4°C 时从 9.92 到 12.41 小时不等，在 20°C 时从 6.31 到 9.13 小时不等。在-20°C 冷冻时，该药物至少稳定 2 个月（损失不超过 10%）。发现最大血浆浓度（Cpmax）为 5875.03±114ng mL-1，明显高于最大唾液浓度（Csmax，1501.69±96ng mL-1）。因此，该验证方法可用于从新型药物传递系统中进行 TBS 的药代动力学研究。
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