Patel Sejal, Patel N J
S. K. Patel College of Pharmaceutical Education and Research, Department of Pharmaceutical Chemistry, Ganpat University, Kherva, Mehsana-382711, India.
Indian J Pharm Sci. 2009 Jul;71(4):477-80. doi: 10.4103/0250-474X.57306.
A binary mixture of fluoxetine HCl and olanzapine was determined by two different methods. The first method involved determination of fluoxetine HCl and olanzapine using reversed-phase liquid chromatography using acetonitrile:methanol:0.032 M ammonium acetate buffer (45:05:50, v/v/v) as the mobile phase at a flow rate of 1.5 ml/min. Quantitation was achieved with ultraviolet detection at 235 nm over concentration ranges of 0.2-4 and 0.1-2 mug/ml; mean accuracies were 101.16+/-0.59 and 99.79+/-0.56% for fluoxetine HCL and olanzapine, respectively. The second method was based on the high performance thin layer chromatography separation of the two drugs followed by densitometric measurements of their spots at 235 nm. The separation was carried out on Merck TLC aluminium sheets of silica gel 60 F254 using acetone:methanol:triethyleamine (5:3:0.5, v/v/v), as mobile phase. The linearity was found to be in the range of 300-1000 and 150-500 ng/spot; mean accuracies were 100.95+/-0.52 and 99.31+/-0.51% for fluoxetine HCl and olanzapine, respectively. The method was successively applied to tablets because no chromatographic interferences from the tablet excipients were found. The methods retained their accuracy and precision when the standard addition technique was applied. The results obtained by applying the proposed methods were statistically analyzed.
采用两种不同方法测定盐酸氟西汀和奥氮平的二元混合物。第一种方法是使用反相液相色谱法测定盐酸氟西汀和奥氮平,以乙腈:甲醇:0.032 M醋酸铵缓冲液(45:05:50,v/v/v)作为流动相,流速为1.5 ml/min。在235 nm波长下采用紫外检测进行定量,盐酸氟西汀和奥氮平的浓度范围分别为0.2 - 4 μg/ml和0.1 - 2 μg/ml;盐酸氟西汀和奥氮平的平均准确度分别为101.16±0.59%和99.79±0.56%。第二种方法基于两种药物的高效薄层色谱分离,随后在235 nm波长下对其斑点进行光密度测量。分离在默克硅胶60 F254 TLC铝板上进行,以丙酮:甲醇:三乙胺(5:3:0.5,v/v/v)作为流动相。线性范围为300 - 1000 ng/斑点和150 - 500 ng/斑点;盐酸氟西汀和奥氮平的平均准确度分别为100.95±0.52%和99.31±0.51%。该方法相继应用于片剂,因为未发现片剂辅料的色谱干扰。当应用标准加入技术时,这些方法保持了其准确度和精密度。对应用所提出方法获得的结果进行了统计分析。