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.


  1. Bilastine. (Accessed 12 Jun 2021).
  2. Montelukast sodium. (Accessed 12 Jun 2021).
  3. Approved new drugs. (Accessed 12 Jun 2021).
  4. Amarendra CV, Anusha K, Muneer S. Method development and validation of new RP-HPLC method for the estimation of Bilastine in pharmaceutical dosage form. World J Pharm Pharm Sci 2017; 6: 2297-315.
  5. Ouarezki R, Guermouche S, Guermouche MH. Degradation kinetics of Bilastine determined by RP-HPLC method and identification of its degradation product in oxidative condition. Chemical Papers 2020; 74:1133-42.
  6. Muralidharan S, Qi LJ, Yi LT, Kaur N, Parasuraman S, Kumar J, et al. Newly developed and validated method of montelukast sodium estimation in tablet dosage form by ultraviolet spectroscopy and reverse phase-high performance liquid chromatography. PTB Reports 2016;2(2):27-30.
  7. Gholve S, Thonte S, Bhusnure O. Rp-Hplc Method Development and Validation Of Montelukast Sodium In Bulk Drug And Dosage Form. Int J Pharm Bio Sci 2015; 6: 354-60.
  8. Gandhi BM, Rao AL, Rao JV. Method development and validation for simultaneous estimation of Montelukast sodium and Desloratadine by RP-HPLC. Am J Analyt Chem 2015; 6: 651.
  9. Somkuwar S, Pathak AK. Simultaneous estimation of levocetirizine dihydrochloride and montelukast sodium by RP-HPLC Method. Pharmacia 2012; 1: 90-4.
  10. Ravisankar M, Uthirapathy S, Thangadurai A, Dhanapal K. simultaneous estimation of fexofenadine hydrocloride and montelukast sodium in bulk drug and marketed formulation by RP-HPLC method. Int Res J Pharm. 2012; 3: 356-9.
  11. Katta R, Murty NNVVSSN, Ramasrinivas, Rao GN: Stability indicating method development and validation for the determination of bilastine and its impurities by UPLC method. Int J Pharm Sci Res 2020; 1: 1312-21.
  12. Shaista F, Rizwan SH. Analytical Method Development And Validation For The Estimation Of Bilastine In Bulk And Pharmaceutical Dosage Form By UPLC. World journal of pharmaceutical and life sciences 2020; 6: 138-43.
  13. Amaresha S, Jhat Rakesh K. RP-UPLC method development and validation for the simultaneous estimation of Montelukast and Ebastine in bulk and pharmaceutical dosage form. Int J Pharma Anal Res 2018; 7: 96-105.
  14. Rathore AS, Lohidasan S, Mahadik KR. Development of Validated HPLC and HPTLC Methods for Simultaneous Determination of Levocetirizine Dihydrochloride and Montelukast Sodium in Bulk Drug and Pharmaceutical Dosage Form. Pharm Anal Acta 2010:106.
  15. Tandulwadkar SS, More SJ, Rathore AS, Nikam AR, Sathiyanarayanan L, Mahadik KR. Method development and validation for the simultaneous determination of fexofenadine hydrochloride and montelukast sodium in drug formulation using normal phase high-performance thin-layer chromatography. International Scholarly Research Notices 2012, 924185.
  16. Mohan raj R, Sankar ASK, Vetrichelvan T. Analytical method development and validation for simultaneous estimation of bilastine and montelukast sodium by uv spectrophotometry. World Journal of Pharmacy and Pharmaceutical Sciences 2020.