S. K. Patel College of Pharmaceutical Education and Research, Department of Pharmaceutical Chemistry, Ganpat University, Kherva, Mehsana, Gujarat, India-382711.
Acta Pharm. 2010 Jun;60(2):197-205. doi: 10.2478/v10007-010-0013-z.
Reversed-phase high-performance liquid chromatography (RP-HPLC) and thin-layer chromatography (TLC) methods have been developed and validated for simultaneous estimation of tamsulosin hydrochloride and finasteride in bulk drug and in combined dosage forms. RP-HPLC separation was achieved on a Phenomenex C18 column using methanol/0.02 mol L-1 ammonium acetate buffer/triethylamine (79.9 + 20 + 0.1, V/V/V) (pH 9.2) as mobile phase. TLC separation was achieved on an aluminium-backed layer of silica gel 60 F254 using toluene/methanol/triethylamine (9 + 1.5 + 1, V/V/V) as eluent. Quantification was achieved with photodiode array (PDA) detection at 235 nm over the concentration range 0.5-16 and 1-50 μg mL-1 with mean recovery of 99.8 ± 0.9 and 100.0 ± 0.8% for tamsulosin hydrochloride and finasteride, respectively, by the RP-HPLC method. Quantification was achieved with UV detection at 270 nm over the concentration range 100-2000 ng per spot and 250-5000 ng per spot with mean recovery of 98.9 ± 0.9 and 99.6 ± 0.7 % for tamsulosin hydrochloride and finasteride, respectively, by the TLC method. Both methods are simple, precise, accurate and sensitive and are applicable to the simultaneous determination of tamsulosin hydrochloride and finasteride in bulk drug and in combined dosage forms.
反相高效液相色谱法（RP-HPLC）和薄层色谱法（TLC）已被开发和验证，用于同时测定盐酸坦索罗辛和非那雄胺原料药和复方制剂中的含量。RP-HPLC 分离在 Phenomenex C18 柱上进行，采用甲醇/0.02mol/L 乙酸铵缓冲液/三乙胺（79.9+20+0.1，V/V/V）（pH9.2）作为流动相。TLC 分离在硅胶 60 F254 铝背层上进行，采用甲苯/甲醇/三乙胺（9+1.5+1，V/V/V）作为洗脱剂。在 0.5-16 和 1-50μg/ml 浓度范围内，用光电二极管阵列（PDA）检测在 235nm 处进行定量，盐酸坦索罗辛和非那雄胺的平均回收率分别为 99.8±0.9%和 100.0±0.8%，用 RP-HPLC 法。在 100-2000ng/点和 250-5000ng/点浓度范围内，用 UV 检测在 270nm 处进行定量，盐酸坦索罗辛和非那雄胺的平均回收率分别为 98.9±0.9%和 99.6±0.7%，用 TLC 法。两种方法均简单、精确、准确、灵敏，适用于盐酸坦索罗辛和非那雄胺原料药和复方制剂的同时测定。
