Analytical Method Development and Validation for Simultaneous Estimation of Bilastine and Montelukast Sodium in their Combined Dosage form by Derivative UV-Spectroscopy and RP-HPLC Method

Riya Mistry, Rajashree Mashru*

The Maharaja Sayajirao University of Baroda, G.H Patel Pharmacy Building, Donor’s Plaza, Fatehgunj, Vadodara-390001, Gujarat, India.

Abstract: Objective: To develop and validate simple, accurate and Derivative UV-Spectroscopy and Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for the simultaneous determination of Bilastine and Montelukast Sodium (MNT) in bulk and pharmaceutical formulations. Experimental approach: In the first derivative UV method methanol was used as a diluent and quantification was achieved at 257 nm and 365 nm over the concentration range of 4-20 μg/mL and 2-10 μg/mL for Bilastine and Montelukast sodium respectively. In RP-HPLC method mixture of Acetonitrile and 20mM Potassium Dihydrogen Orthophosphate buffer (pH 3.5) in the ratio of 80:20 v/v was used as mobile phase, at a flow rate of 1.2 ml/min. Findings and Discussion: The linearity range for Bilastine and Montelukast sodium was found to be 10-50 μg/ml and 5- 25μg/ml respectively. The correlation coefficient value for both the methods were greater than 0.996. Accuracy of the methods was determined by recovery studies and it was found to be in the range of 98- 101%. The % RSD values for all the validation parameters were less than 2 % for both the methods. Conclusion: Both the developed methods are equally significant and can be used for simultaneous estimation of Bilastine and Montelukast sodium in their combined dosage form.


Keywords:Bilastine, Montelukast Sodium, First Derivative UV-Spectroscopy, RP-HPLC, Validation.

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