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

RAMULU, Gajjela; RAVINDRA KUMAR, Yalavarthi; VYAS, Krishnamurthy; SURYANARAYANA, Mulukutla V.; MUKKANTI, Khagga

doi:10.3797/scipharm.1012-13

Open AccessArticle

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

by

Gajjela RAMULU

^1,2,*,

Yalavarthi RAVINDRA KUMAR

¹,

Krishnamurthy VYAS

¹,

Mulukutla V. SURYANARAYANA

¹ and

Khagga MUKKANTI

²

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.

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

Submission 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

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MDPI and ACS Style

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. https://doi.org/10.3797/scipharm.1012-13

AMA Style

RAMULU G, RAVINDRA KUMAR Y, VYAS K, SURYANARAYANA MV, MUKKANTI K. A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities. Scientia Pharmaceutica. 2011; 79(2):277-292. https://doi.org/10.3797/scipharm.1012-13

Chicago/Turabian Style

RAMULU, Gajjela, Yalavarthi RAVINDRA KUMAR, Krishnamurthy VYAS, Mulukutla V. SURYANARAYANA, and Khagga MUKKANTI. 2011. "A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities" Scientia Pharmaceutica 79, no. 2: 277-292. https://doi.org/10.3797/scipharm.1012-13

APA Style

RAMULU, G., RAVINDRA KUMAR, Y., VYAS, K., SURYANARAYANA, M. V., & MUKKANTI, K. (2011). A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities. Scientia Pharmaceutica, 79(2), 277-292. https://doi.org/10.3797/scipharm.1012-13

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

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