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Volume 81
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Article

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

by
Palakurthi Ashok KUMAR
1,*,
Thummala Veera Raghava RAJU
1,
Dongala THIRUPATHI
1,
Ravindra KUMAR
1 and
Jaya SHREE
2
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.
Sci. Pharm. 2013, 81(1), 139-150; https://doi.org/10.3797/scipharm.1210-18
Submission received: 18 October 2012 / Accepted: 17 November 2012 / Published: 17 November 2012
Versions Notes

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

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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. https://doi.org/10.3797/scipharm.1210-18

AMA Style

KUMAR PA, RAJU TVR, 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. Scientia Pharmaceutica. 2013; 81(1):139-150. https://doi.org/10.3797/scipharm.1210-18

Chicago/Turabian Style

KUMAR, Palakurthi Ashok, Thummala Veera Raghava RAJU, Dongala THIRUPATHI, Ravindra KUMAR, and Jaya SHREE. 2013. "Development and Validation of a Stability-Indicating LC-Method for the Simultaneous Estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurities" Scientia Pharmaceutica 81, no. 1: 139-150. https://doi.org/10.3797/scipharm.1210-18

APA Style

KUMAR, P. A., RAJU, T. V. R., THIRUPATHI, D., KUMAR, R., & SHREE, J. (2013). Development and Validation of a Stability-Indicating LC-Method for the Simultaneous Estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurities. Scientia Pharmaceutica, 81(1), 139-150. https://doi.org/10.3797/scipharm.1210-18

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