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Sci. Pharm. 2013, 81(1), 139-150; doi:10.3797/scipharm.1210-18

Development and Validation of a Stability-Indicating LC-Method for the Simultaneous Estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurities

1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
Centre for Chemical Science and Technology, J. N. T. University, Kukatpally, Hyderabad, A.P., India
*
Author to whom correspondence should be addressed.
Received: 18 October 2012 / Accepted: 17 November 2012 / Published: 17 November 2012
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Abstract

A simple, fast, and efficient RP-HPLC method has been developed and validated for the simultaneous estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and the quantification of Levodropropizine impurities in the Reswas syrup dosage form. A gradient elution method was used for the separation of all the actives and Levodropropizine impurities by using the X-Bridge C18, 150 mm × 4.6 mm, 3.5 μm column with a flow rate of 1.0 mL/min and detector wavelength at 223 nm. The mobile phase consisted of a potassium dihydrogen orthophosphate buffer and acetonitrile. All the peaks were symmetrical and well-resolved (resolution was greater than 2.5 for any pair of components) with a shorter run time. The limit of detection for Levodropropizine and its Impurity B was 0.07 μg/ml & 0.05 μg/ml, whereas the limit of quantification was 0.19 μg/ml & 0.15 μg/ml respectively. The method was validated in terms of precision, accuracy, linearity, robustness, and specificity. Degradation products resulting from the stress studies were well-resolved and did not interfere with the detection of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurity B, thus the test method is stability-indicating. Validation of the method was carried out as per International Conference on Harmonization (ICH) guidelines.
Keywords: l-Dropropizine; Chloropheniramine; HPLC; ICH Guidelines; Development; Validation l-Dropropizine; Chloropheniramine; HPLC; ICH Guidelines; Development; 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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MDPI and ACS Style

KUMAR, P.A.; RAJU, T.V.R.; THIRUPATHI, D.; KUMAR, R.; SHREE, J. Development and Validation of a Stability-Indicating LC-Method for the Simultaneous Estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurities. Sci. Pharm. 2013, 81, 139-150.

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