HPTLC 密度测定法同时测定干粉吸入器中沙美特罗替卡松和丙酸氟替卡松。
HPTLC-densitometric method for simultaneous determination of salmeterol xinafoate and fluticasone propionate in dry powder inhalers.
机构信息
Department of Pharmaceutical Chemistry, School of Pharmacy, Addis Ababa University, Ethiopia.
出版信息
Saudi Pharm J. 2010 Jul;18(3):153-9. doi: 10.1016/j.jsps.2010.05.001. Epub 2010 May 31.
Abstract
A high performance thin layer chromatography (HPTLC) method was developed and validated for determination of two anti-asthmatic drugs, salmeterol xinafoate and fluticasone propionate in co-formulations. Study was performed on pre-coated silica gel HPTLC plates using n-hexane:ethyl acetate:acetic acid (5:10:0.2) as a mobile phase. A TLC scanner set at 250 nm was used for direct evaluation of the chromatograms in reflectance/absorbance mode. Method was validated according to ICH guidelines. Determination coefficients of calibration curves were found 0.9977 and 0.9936 in the ranges 100-1000 and 200-2000 ng band(-1) for salmeterol and fluticasone, respectively. Method had an accuracy of 99.5% for salmeterol and 102.01% for fluticasone. Method had the potential to determine these drugs simultaneously from dosage forms without any interference.
摘要
建立并验证了一种高效薄层色谱（HPTLC）法，用于同时测定复方制剂中两种抗哮喘药物沙美特罗昔萘酸酯和丙酸氟替卡松的含量。该方法在涂覆有硅胶的 HPTLC 板上进行，采用正己烷：乙酸乙酯：乙酸（5:10:0.2）作为流动相。采用 TLC 扫描仪在 250nm 下以反射/吸收模式对色谱图进行直接评估。该方法根据 ICH 指南进行了验证。沙美特罗和丙酸氟替卡松的校准曲线测定系数分别在 100-1000ng 带（-1）和 200-2000ng 带（-1）范围内为 0.9977 和 0.9936。沙美特罗的准确度为 99.5%，丙酸氟替卡松的准确度为 102.01%。该方法无需任何干扰即可从制剂中同时测定这些药物。
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