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高效柱液相色谱法和高效薄层色谱法同时测定片剂制剂中阿普唑仑和盐酸氟西汀的含量

Simultaneous determination of alprazolam and fluoxetine hydrochloride in tablet formulations by high-performance column liquid chromatography and high-performance thin-layer chromatography.

作者信息

Patel Rashmin B, Patel Mrunali R, Shankar Madhira B, Bhatt Kashyap K

机构信息

Sardar Patel University, A.R. College of Pharmacy & G.H. Patel Institute of Pharmacy, Vallabh Vidyanagar 388120, Gujarat, India.

出版信息

J AOAC Int. 2009 Jul-Aug;92(4):1082-8.

Abstract

This paper describes validated HPLC and HPTLC methods for simultaneous determination of alprazolam (ALP) and fluoxetine hydrochloride (FXT) in pure powder and formulation. The HPLC separation was achieved on a Nucleosil C8 column (150 mm length, 4.6 mm id, 5 microm particle size) using acetonitrile-phosphate buffer pH 5.5 (45 + 55, v/v) as the mobile phase at a flow rate of 1.0 mL/min at ambient temperature. The HPTLC separation was achieved on an aluminum-backed layer of silica gel 60F254 using acetone-toluene-ammonia (6.0 + 3.5 + 0.5, v/v/v) as the mobile phase. Quantification in the HPLC method was achieved with UV detection at 230 nm over the concentration range 4-14 microg/mL for both drugs, with mean recovery of 99.95 +/- 0.38 and 99.85 +/- 0.56% for ALP and FXT, respectively. Quantification in the HPTLC method was achieved with UV detection at 230 nm over the concentration range of 400-1400 ng/spot for both drugs, with mean recovery of 99.32 +/- 0.45 and 99.78 +/- 0.81% for ALP and FXT, respectively. These methods are simple, precise, and sensitive, and they are applicable for the simultaneous determination of ALP and FXT in pure powder and formulations.

摘要

本文描述了用于同时测定纯粉末和制剂中阿普唑仑(ALP)和盐酸氟西汀(FXT)的经过验证的高效液相色谱(HPLC)和高效薄层色谱(HPTLC)方法。HPLC分离是在Nucleosil C8柱(柱长150 mm,内径4.6 mm,粒径5微米)上进行的,使用乙腈 - pH 5.5的磷酸盐缓冲液(45 + 55,v/v)作为流动相,在室温下流速为1.0 mL/min。HPTLC分离是在硅胶60F254铝背层上进行的,使用丙酮 - 甲苯 - 氨(6.0 + 3.5 + 0.5,v/v/v)作为流动相。HPLC法的定量是通过在230 nm处进行紫外检测实现的,两种药物的浓度范围均为4 - 14微克/毫升,阿普唑仑和盐酸氟西汀的平均回收率分别为99.95 +/- 0.38%和99.85 +/- 0.56%。HPTLC法的定量是通过在230 nm处进行紫外检测实现的,两种药物的浓度范围均为400 - 1400纳克/斑点,阿普唑仑和盐酸氟西汀的平均回收率分别为99.32 +/- 0.45%和99.78 +/- 0.81%。这些方法简单、精确且灵敏,适用于同时测定纯粉末和制剂中的阿普唑仑和盐酸氟西汀。

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