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.
Highlights
Levodropropizine (LDP), a phenylpiperazinopropane derivative, is a non-opioid antitussive agent
Chloropheniramine (CP) is a first-generation antihistamine belonging to the class of alkylamines
Microorganisms tend to grow in an aqueous phase, so to prevent their growth, a preservative has to be added to the pharmaceutical composition
Summary
Levodropropizine (LDP), a phenylpiperazinopropane derivative, is a non-opioid antitussive agent. Chloropheniramine (CP) is a first-generation antihistamine belonging to the class of alkylamines It is used in the prevention of symptoms of allergic conditions such as rhinitis and utricaria. Its sedative effects are relatively weak compared to other first-generation antihistamines. It is used for the treatment of cough, and for other related allergy symptoms such as sneezing, itchy and/or watery eyes, itchy nose or throat, and runny nose caused by hay fever (allergic rhinitis), or other respiratory allergies. Methylparaben (MP) and Propylparaben (PP) are the preservatives used to prevent decomposition by microbial growth or by undesirable chemical changes. Microorganisms tend to grow in an aqueous phase, so to prevent their growth, a preservative has to be added to the pharmaceutical composition.
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