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A Validated Densitometric Method for Duloxetine Hydrochloride in pharmaceutical dosage form

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Author(s): M.C. Sharma1, S. Sharma *, A.D. Sharma2

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 5;
Start page: 1538;
Date: 2011;
Original page

Keywords: Duloxetine Hydrochloride | TLC Densitometric | Stability indicating.

ABSTRACT
A rapid and simple high performance thin layer chromatography method with densitometry 295 nm was developed and validated for simultaneous determination of Duloxetine Hydrochloride from pharmaceutical preparation. Separation was performed on aluminium-backed silica gel 60F254 HPTLC plates as stationary phase and using a mobile phase comprising of ethyl Acetate: carbon tetrachloride: Methanol: toluene: Glacial acetic acid (2:1.2:0.5:3.5:0.5:1.0 v/v/v/v/v) respectively. After development, plates were observed under UV light. The detector response was linear in the range of 12.2 to 20.1 μg/spot for Duloxetine Hydrochloride. Both the drugs were subjected to stress test conditions like acid/ alkali/ neutral hydrolysis, oxidation, dry heat treatment and photo degradation. The spots for product of degradation were well resolved from the spot of respective drugs. The linear regression analysis data for the calibration plots showed good linear relationship with coefficient of regression value, r2= 0.9996. The method was validated in accordance with ICH guidelines. There was no chromatographic interference from capsule excipients. Developed method was validated in terms of linearity, accuracy, precision, repeatability and specificity.
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