Venkateswarlu K, Venisetty R K, Yellu N R, Keshetty S, Pai M G
Department of Pharmaceutical Analysis, Goa College of Pharmacy, Panaji, Goa, India.
J Chromatogr Sci. 2007 Sep;45(8):537-9. doi: 10.1093/chromsci/45.8.537.
A new simple, sensitive, and reproducible high-performance thin-layer chromatography method for the estimation of alprazolam and sertraline in combination is developed using silica gel plates with fluorescent indicators. The system is equipped with an automated sample applicator, and the detection was performed at 254 nm by using UV absorption densitometry. The mobile phase consists of carbon tetrachloride, methanol, acetone, and ammonia in the ratio 12:3:5:0.1. The retention factor values for alprazolam and sertraline are found to be 0.52 and 0.70, respectively. The limit of detection of alprazolam and sertraline in the mixture of given proportion is observed to be 0.05 microg/mL and 2.5 microg/mL and the limit of quantitation is 0.2 microg/mL and 10 microg/mL, respectively. The method has shown good linearity in the range of 0.2 microg/mL to 0.65 pg/mL for alprazolam (R2 > 0.9953) and 10 pg/mL to 32.5 microg/mL for sertraline (R2 > 0.9942). The intra- and inter-assay (n=5) variations in the linear range are less than 4% for alprazolam and 6% for sertraline. Three pharmaceutical products containing this combination are analyzed to test the applicability of the new method. The percentage of alprazolam and sertraline in the tablets studied range from 97.7% to 102.82% and 96.5% to 99.9%, respectively.
建立了一种新的简单、灵敏且可重现的高效薄层色谱法，用于同时测定阿普唑仑和舍曲林。该方法使用带有荧光指示剂的硅胶板，系统配备自动进样器，并采用紫外吸收光密度法在254nm波长处进行检测。流动相由四氯化碳、甲醇、丙酮和氨按12:3:5:0.1的比例组成。阿普唑仑和舍曲林的保留因子值分别为0.52和0.70。在给定比例的混合物中，阿普唑仑和舍曲林的检测限分别为0.05μg/mL和2.5μg/mL，定量限分别为0.2μg/mL和10μg/mL。该方法在阿普唑仑0.2μg/mL至0.65μg/mL范围内（R2>0.9953）以及舍曲林10μg/mL至32.5μg/mL范围内（R2>0.9942）显示出良好的线性。在该线性范围内，阿普唑仑的批内和批间（n = 5）变异小于4%，舍曲林小于6%。对三种含有该组合的药品进行分析，以测试该新方法的适用性。所研究片剂中阿普唑仑和舍曲林的含量分别在97.7%至102.82%和96.5%至99.9%之间。
