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Sci. Pharm. 2011, 79(1), 97-112; doi:10.3797/scipharm.1009-12

Development and Validation of a Stability Indicating RP-UPLC Method for Determination of Quetiapine in Pharmaceutical Dosage Form

1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
P. S. Science and H. D. Patel Arts College, S. V. Campus, Kadi-382 715, Gujarat, India
*
Author to whom correspondence should be addressed.
Received: 25 September 2010 / Accepted: 16 January 2011 / Published: 16 January 2011
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Abstract

The present work reports a stability indicating reversed phase ultra performance liquid chromatography (RP-UPLC) method for the quantitative determination of quetiapine in pharmaceutical dosage form. The chromatographic separation is performed on an Agilent Eclipse Plus C18, RRHD 1.8 μm (50 mm x 2.1 mm) column using gradient elution. The optimized mobile phase consists of 0.1 % aqueous triethylamine (pH 7.2) as a solvent-A and 80:20 v/v mixture of acetonitrile and methanol as solvent-B. The eluted compounds are monitored at 252 nm wavelength using a UV detector. The developed method separates quetiapine from its five impurities/degradation products within a run time of 5 min. Stability indicating capability of the developed method is established by analyzing forced degradation samples in which the spectral purity of quetiapine is ascertained along with the separation of degradation products from analyte peak. The developed RP-UPLC method is validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, accuracy, linearity, robustness and filter compatibility.
Keywords: Seroquel; Assay; Method validation; Degradation products; Rapid; Chromatography Seroquel; Assay; Method validation; Degradation products; Rapid; Chromatography
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

TRIVEDI, R.K.; PATEL, M.C. Development and Validation of a Stability Indicating RP-UPLC Method for Determination of Quetiapine in Pharmaceutical Dosage Form. Sci. Pharm. 2011, 79, 97-112.

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