Patel Rashmin B, Patel Mrunali R, Shankar Madhira B, Bhatt Kashyap K
Sardar Patel University, A.R. College of Pharmacy & G.H. Patel Institute of Pharmacy, Vallabh Vidyanagar 388120, Gujarat, India.
J AOAC Int. 2009 Jul-Aug;92(4):1082-8.
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.
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。