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Development and validation of novel RP-UPLC method for estimation of atropine sulphate in pharmaceutical dosage form

Author(s): Arvadiya A.C. | Dahivelker P.P.

Journal: Chemical Industry and Chemical Engineering Quarterly
ISSN 1451-9372

Volume: 19;
Issue: 3;
Start page: 333;
Date: 2013;
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Keywords: atropine sulphate | method validation | reversed phase ultra pressure liquid chromatography

A simple, precise, accurate, sensitive and repeatable RP-UPLC method was developed for quantitative determination of atropine sulphate in pharmaceutical dosage form. The method was developed by using C18 column Hiber HR Purospher Star (100mm×2.1mm id, 2μm particle size) as stationary phase with Phosphate Buffer: Acetonitrile (87:13, %v/v) as a mobile phase, pH was adjusted to 3.5 by ortho-phosphoric acid at a flow rate of 0.5 mL/min and column temperature maintained at 30°C. Quantification of eluted compound was achieved with PDA detector at 210 nm. Atropine sulphate followed linearity in concentration range of 2.5-17.5 μg/mL with r2=0.9998 (n=6). Limit of detection (LOD) and limit of quantification (LOQ) values were 0.0033 and 0.0102 μg/mL for atropine sulphate. The validation study is carried out as per International Conference on Harmonization (ICH) guidelines. This method was successfully applied for estimation of atropine sulphate in pharmaceutical formulation.
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