Simultaneous Determination of Alprazolam and Fluoxetine Hydrochloride in Tablet Formulations by High-Performance Column Liquid Chromatography and High-Performance Thin-Layer Chromatography

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-...

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Bibliographic Details
Published in:Journal of AOAC International 2009-07, Vol.92 (4), p.1082-1088
Main Authors: PATEL, Rashmin B, PATEL, Mrunali R, SHANKAR, Madhira B, BHATT, Kashyap K
Format: Article
Language:English
Subjects:
Alprazolam
Alprazolam - analysis
Anti-Anxiety Agents - analysis
Antidepressive Agents, Second-Generation - analysis
Biological and medical sciences
Calibration
Chemical properties
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Chromatography, Thin Layer
Composition
Fluoxetine
Fluoxetine - analysis
Food industries
Fundamental and applied biological sciences. Psychology
High performance liquid chromatography
Identification and classification
Indicators and Reagents
Methods
Reference Standards
Reproducibility of Results
Solutions
Tablets
Tablets (Medicine)
Thin layer chromatography
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Summary: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.
ISSN:1060-3271
1944-7922
DOI:10.1093/jaoac/92.4.1082