Development and validation of a stability-indicating LC-method for the simultaneous estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine impurities

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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. © Kumar et al.

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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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