Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF LEVOCETIRIZINE HYDROCHLORIDE AND MONTELUKAST SODIUM AS BULK DRUGS AND IN TABLET DOSAGE FORM

Janvi Bhatt, Padmanabh Deshpande*, Neha Deore, Yogesh Gandhi, Ganesh Sarowar

ABSTRACT

A new simple, accurate, precise and selective stability- indicating High Performance Thin Layer Chromatographic (HPTLC) method has been developed and validated for simultaneous determination of Levocetirizine Hydrochloride and Montelukast Sodium in combined tablet dosage form. The mobile phase selected was Toluene: Ethyl Acetate: Methanol (2.5: 5: 2.5, v/v/v) with UV detection at 240 nm. The retention factors for Levocetirizine Hydrochloride and Montelukast Sodium were found to be 0.17 ± 0.06 and 0.76 ± 0.04, respectively. The method was validated with respect to linearity, accuracy, precision and robustness as recommended by ICH. The drugs were subjected to stress condition of hydrolysis, oxidation, photolysis and thermal degradation. Results were found to be linear in the concentration range of 100-500 ng band-1 for Levocetirizine Hydrochloride and 200-1000 ng band-1 for Montelukast Sodium. The method has been successfully applied for the analysis of drug in pharmaceutical formulation. The % assay (Mean ± S.D.) was found to be 99.14 ± 0.36 for Levocetirizine Hydrochloride and 99.28 ± 0.66 for Montelukast Sodium, respectively. The developed method can be used for accessing the stability of Levocetirizine Hydrochloride and Montelukast Sodium in bulk drug and pharmaceutical tablet dosage form.

Keywords: Levocetrizine hydrochloride, Montelukast Sodium, HPTLC, Forced degradation, Validation.