In-Vitro Comparative Study of Levocetirizine Dihydrochloride and Montelukast Sodium Release Profiles in Xyzal M Suspension and Other Marketed Syrup Formulations
Abstract
Objectives: In-vitro comparative analysis of the release profile of levocetirizine dihydrochloride and montelukast sodium in Xyzal M Suspension and three commercially available syrup formulations.
Method: The active components and their impurities were initially assayed in all formulations using a validated HPLC method. The enantiomeric impurities of montelukast sodium in different pH media were determined using the HPLC method specified in the United State Pharmacopoeia (USP) monograph. Additionally, dissolution studies and the soluble fractions of the components were evaluated in pH media that mimic the conditions of the gastrointestinal tract. The particle size was also analyzed using microscopic analysis. All parameters were examined in fresh, stressed, and aged samples of each formulation.
Results: The assay results indicate the claimed potency of formulations. The total and enantiomeric impurities meet the limits set by the Indian Pharmacopoeia (<2%) and USP monograph (<0.2%), respectively. The particle size analysis demonstrated that montelukast remained suspended throughout the Xyzal M suspension. Levocetirizine in all formulations exhibited a soluble fraction of >70% after 1 and 24 hours in various pH media. For montelukast, the soluble fraction exceeded 50% in all syrup formulations. However, in Xyzal M suspension, montelukast was found to be 100% insoluble in all pH media after 1 and 24 hours, except in simulated intestinal fluid (~40-45%) after 24 hours. The absence of S-enantiomer, even in simulated intestinal fluid, indicates its presence in the pharmacologically active form.
Conclusion: Xyzal M suspension is a promising dosage formulation for achieving desired pharmacological action, outperforming the syrup formulations.
Keywords: Levocetirizine dihydrochloride, Montelukast sodium, Release profile, Suspension, Syrup, S-enantiomer
Keywords:
Levocetirizine dihydrochloride, Montelukast sodium, Release profile, Suspension, Syrup, S-enantiomerDOI
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