alexa Abstract | Development and validation of rp-hplc method for the simultaneous estimation of montelukast sodium and ebastine in tablet dosage form

Indian Journal of Pharmaceutical Sciences
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Research Paper Open Access


A rapid and sensitive RP-HPLC method with UV detection (244 nm) for routine analysis of montelukast sodium and ebastine in a pharmaceutical formulation (Ebast-M) was developed. Chromatography was performed with mobile phase containing a mixture of methanol:acetonitrile:ammonium acetate (80:10:10, % v/v/v), pH of mobile phase was adjusted 5.5 using glacial acetic acid and flow rate was 1.2 ml/min. The method was validated for linearity, accuracy, robustness and intermediate precision. The linearity was established over the concentration range of 0.01−0.06 mg/ml for both drugs. The correlation coefficients (r 2) for ebastine and montelukast were 0.9989 and 0.9955, respectively. Statistical analysis of the data showed that the method was precise, accurate, reproducible and selective for the analysis of ebastine and montelukast drugs. The method was successfully employed for the determination of ebastine and montelukast in commercially available tablet dosage form.

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Author(s): NS Rana KS Rajesh Nikita N Patel PR Patel U Limbachiya TY Pasha


Ebastine, method validation, montelukast, reversed-phase high-performance liquid chromatography, tablets

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