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Development and Validation of High Performance Thin-Layer Chromatographic Method for Determination of Atomoxetine Hydrochloride in Pharmaceutical Dosage Forms | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X
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Abstract

Development and Validation of High Performance Thin-Layer Chromatographic Method for Determination of Atomoxetine Hydrochloride in Pharmaceutical Dosage Forms

Author(s): Hetal R. Prajapati, Paras N. Raveshiya, Bhavesh B. Jadav, Divyesh M. Mahakal

New simple, accurate, precise, rapid, selective and reproducible high performance thin layer chromatographic method for quantitative analysis of atomoxetine hydrochloride as the bulk drug and in pharmaceutical formulations has been established and validated. High performance thin layer chromatography (HPTLC) on aluminium - backed silica gel 60F254 plates with methanoltriethylamine 10:0.5 (v/v) as mobile phase was followed by densitometry measurement at 270 mm. This system was found to give compact bands for atomoxetine hydrochloride (RF 0.55 ± 0.02). Calibration plots were linear in the range 300 - 1800 ng per spot with correlation coefficient 0.9986. The recovery was in the range of 98.10 - 99.85 %. The method was validated in accordance with ICH guidelines and can be used for analysis of marketed formulations.


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