Shivarkar N A, Dudhe P B, Nagras M A
Department of Pharmaceutical Chemistry, Sinhgad College of Pharmacy, Vadgaon (Bk), Pune-411 041, India.
Indian J Pharm Sci. 2013 May;75(3):364-8. doi: 10.4103/0250-474X.117418.
A simple, precise, accurate, and rapid high-performance thin layer chromatographic method has been developed and validated for the simultaneous quantitation of flunarizine dihydrochloride and propranolol hydrochloride in a combined capsule dosage form. The method was carried out on precoated silica gel 60 F254 TLC aluminum plate, (20×10 cm(2)). The solvent system was ethyl acetate:methanol:glacial acetic acid in the proportion of 8:1:1, (v/v/v). R f value for flunarizine dihydrochloride and propranolol hydrochloride was found to be 0.62±0.02 and 0.18±0.02, respectively. The linearity regression analysis for calibration showed 0.999 and 0.999 for flunarizine dihydrochloride and propranolol hydrochloride with respect to peak area and height in the concentration range of 50-350 ng/spot and 500-3500 ng/spot, respectively. Accuracy of recovery studies was found to be 98-100.28 and 99.11-99.45% for flunarizine dihydrochloride and propranolol hydrochloride, respectively. The amounts of drug in marketed formulation were 100.5 and 101.25% of flunarizine dihydrochloride and propranolol hydrochloride, respectively. The method developed can be used for routine analysis in bulk drug and capsule dosage form.
已开发并验证了一种简单、精确、准确且快速的高效薄层色谱法，用于同时定量复方胶囊剂型中盐酸氟桂利嗪和盐酸普萘洛尔的含量。该方法在预涂硅胶60 F254 TLC铝板（20×10 cm(2)）上进行。溶剂系统为乙酸乙酯:甲醇:冰醋酸，比例为8:1:1（v/v/v）。盐酸氟桂利嗪和盐酸普萘洛尔的Rf值分别为0.62±0.02和0.18±0.02。校准的线性回归分析表明，盐酸氟桂利嗪和盐酸普萘洛尔在浓度范围分别为50 - 350 ng/点和500 - 3500 ng/点时，峰面积和峰高的线性相关系数分别为0.999和0.999。回收率研究的准确度分别为：盐酸氟桂利嗪98 - 100.28%，盐酸普萘洛尔99.11 - 99.45%。市售制剂中药物含量分别为盐酸氟桂利嗪的100.5%和盐酸普萘洛尔的101.25%。所开发的方法可用于原料药和胶囊剂型的常规分析。
