Development of Validated HPLC and HPTLC Methods for Simultaneous Determination of Levocetirizine Dihydrochloride and Montelukast Sodium in Bulk Drug and Pharmaceutical Dosage Form

Abstract

Two chromatographic methods have been described for the simultaneous determination of levocetirizine dihydrochloride and Montelukast sodium in tablets. The fi rst method was a high performance thin layer chromatographic (HPTLC) separation followed by densitometric measurements on normal phase silica gel 60 F 254 . The second method was a high performance liquid chromatographic (HPLC) separation on a BDS Hypersil C 18 column using disodium hydrogen phosphate buffer (0.02 M): Methanol (25: 75, v/v) pH adjusted to 7 with ortho-phosphoric acid as the mobile phase. The proposed methods were validated as per ICH guidelines and successfully applied for the determination of investigated drugs in tablets.