Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF EBASTINE AND MONTELUKAST IN ITS COMBINED DOSAGE FORMS

*Hitesh. J. Vekaria¹, Dr. B. D. Patel²

ABSTRACT

A simple, precise, specific and accurate high performance thin layer chromatographic method has been developed for the simultaneous determination of Ebastine (EBA) and Montelukast (MONT) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminum plates of silica gel G60 F254, (10 × 10 cm) with 250 μm thickness using Toluene : ethyl acetate : methanol : Ammonia(30%) (6 : 3.4 : 3 : 0.1, v/v/v/v) as mobile phase. HPTLC separation of the two drugs followed by densitometric measurement was carried out in the absorbance mode at 265 nm. The drugs were resolved satisfactorily with Rf values of 0.82 ± 0.01 and 0.42 ± 0.01 for EBA and MONT, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with R2=0.9985 and 0.9989 for EBA and MONT, respectively in the concentration range of 100-500 ng/spot for both drugs. The method was validated for accuracy, precision, specificity and robustness. The limit of detection and quantitation were 5.1914 and 15.7315 ng/spot, respectively for EBA and 6.7838 and 20.5569 ng/spot, respectively for MONT. The proposed developed HPTLC method can be applied for identification and quantitative determination of EBA and MONT in bulk drug and drug formulation.

Keywords: Montelukast; Ebastine; HPTLC; Validation.