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Sci. Pharm. 2011, 79(2), 277-292; doi:10.3797/scipharm.1012-13

A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities

1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500072, India
2
Center for Pharmaceutical Sciences, IST, J. N. T. University, Kukatpally, Hyderabad-500072, A.P, India
*
Author to whom correspondence should be addressed.
Received: 12 December 2010 / Accepted: 10 February 2011 / Published: 12 February 2011
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Abstract

An improved gradient, reversed-phase liquid chromatographic (RP-LC) method was developed and subsequently validated for the determination of Loratadine and its impurities/degradation products in pharmaceutical drug substance. Separation was achieved with Inertsil ODS-3V, 250 x 4.6 mm, 5μ column with gradient elution at a flow rate of 1.0 mL min−1. UV detection was performed at 220 nm. The described method is linear over a range of LOQ (0.044, 0.088, 0.084, and 0.072 μg mL−1 for impurity-B, impurity-C, impurity-D, and impurity-E respectively) to 1.2 μg mL−1 (0.6 μg mL−1 of the specification limit) for all the impurities and degradation products. The recovery of impurities were found to be in the range of 85–115 %. The method is simple, selective, and accurate for the quantification of impurities and degradation products of Loratadine in its bulk drug samples.
Keywords: Loratadine; Related impurities; Stability Indicating; RP-LC; Validation Loratadine; Related impurities; Stability Indicating; RP-LC; Validation
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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RAMULU, G.; RAVINDRA KUMAR, Y.; VYAS, K.; SURYANARAYANA, M.V.; MUKKANTI, K. A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities. Sci. Pharm. 2011, 79, 277-292.

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