A New Simple RP-HPLC Method Development, Validation and Stability Studies for the Simultaneous Estimation of Montelukast and Ebastine in Pure Form and Combined Tablet Formulation

Author(s): T. Shireesha*, V. Narmada and R. Shyamsunder

Abstract: Objective: The objective of the present research work was to develop an innovative, simple, and economic method for estimation of Montelukast and Ebastine in bulk and dosage form by RP-HPLC. Methods: The chromatographic conditions were performed on Phenomenex Luna C18, 100A, 5μm, 250mmx4.6mm i.d.as stationary phase and mobile phase was prepared with a mixture of Acetonitrile: Phosphate buffer (pH – 3.0) 1.0 ml/min, with Injection Volume 20μl, at detection wavelength 255 nm and run time at 14.0 min. Results: The analytical method is valid for estimation of Montelukast and Ebastine over a range of 0-16 μg/ml, 0-35 μg/ml. The results of system suitability test, linearity, precision and accuracy, robustness, specificity, LOD and LOQ and stabilities presented in this report are within the acceptance range. Conclusion: A specific, sensitive, economic method estimation of Montelukast and Ebastine has been developed based on ICH Guidelines with bulk and dosage forms.

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