Development and Validation of a Reversed-Phase HPLC Method for Simultaneous Estimation of Rupatadine Fumarate and Montelukast Sodium from Their Combined Dosage Forms
More details
Hide details
Hindu College of Pharmacy, Guntur - 522 002, A.P., India
V. V. Institute of Pharmaceutical Sciences, Gudlavalleru - 521 356, A.P., India
A. Lakshmana Rao   

V. V. Institute of Pharmaceutical Sciences, Gudlavalleru - 521 356, A.P., India
Publication date: 2017-10-05
Eurasian J Anal Chem 2014;9(1):49–57
A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the simultaneous estimation of Rupatadine Fumarate and Montelukast Sodium from their combination drug product. The proposed method is based on the separation of the two drugs in reversed-phase mode using Symmetry C-8 analytical column (150 x 4.6 mm; 5 µ). The optimum mobile phase consisted of acetonitrile: phosphate buffer pH 4.7 adjusted with o-phosphoric acid (60:40, v/v), mobile phase flow rate of 1.2 mL min-1 and UV detection was set at 254 nm. The retention times were 3.22 and 10.67 min. for Rupatadine Fumarate and Montelukast Sodium, respectively. The method was validated according to ICH guidelines. It was found to be accurate and reproducible. Linearity was obtained in the concentration range of 100-300 µg mL-1for both Rupatadine Fumarate and Montelukast Sodium with correlation coefficients of 0.999 and 0.999 respectively. Mean percent recovery of triplicate samples at each level for both drugs were found in the range of 98.7% to 99.5% with RSD of less than 2.0%. The proposed method can be successfully applied in the quality control of bulk manufacturing and pharmaceutical dosage forms.
Del Cuvillo A, Mullol J, Bastsa J, Davila I and Montoro J (2006) Comparative pharmacology of the H1 antihistamines. J Investig Allergol Clin Immunol 16: 3-12.
Anick L, Claudine F and Guy M (2006) Montelukast regulates eosinophil protease activity through leukotriene independent mechanism. J Allergy clin Immunology 118 (1): 113-119.
Anju G, Sharma C S and Singh G (2010) Development of UV and Visible spectrophotometric methods for estimation of Rupatadine Fumarate from tablet formulation. Int J Pharm Dev 2(4): 10.
Rele R V, Desai P D and Sawant A (2010) Simple extractive spectrophotometric determination of Rupatadine Fumarate from pharmaceutical formulations. Int J Chem Sci 8(1): 22-28.
Patel P G, Vaghela V M, Rathi S G and Rajgor N B (2009) Derivative spectrophotometry method for simultaneous estimation of Rupatadine and Montelukast in their combined dosage form. J Young pharmacists 1(4): 354-358.
Patel D J, Patel S A, Patel S K (2010) Simultaneous determination of Montelukast Sodium and Bambuterol Hydrochloride in tablet dosage form by UV spectrophotometry (Dual wavelength method). Int J Pharm Biomed Res 1(3): 71-75.
Vishnu P, Anamika N, Satish A and Abhijit S (2011) Derivative and absortive factor spectrophotometric estimation of Montelukast Sodium and Levocetrizine Dihydrochloride from pharmaceutical formulation. Res J Pharm Tech 4(03): 386-389.
Patel N K and Pancholi S (2011) Spectrophotometric determination of Montelukast Sodium and Levocetrizine Dihydrochloride in tablet dosage form by AUC curve method. Der Pharma chemica 3(5): 135-140.
Choudhari V, Kale A, Abnane S and Gawli V (2010) Simultaneous determination of Montelukast Sodium and Levocitrizine Dihydrochloride in pharmaceutical preparation by ratio derivative spectroscopy. Int J Pharm Tech 2(1): 04-09.
Yuan T, Jingjing Z, Jiabi L and Yun C (2008) High performance liquid chromatography – tandem mass spectrometric determination of Rupatadine in human plasma and its pharmacokinetics. J Pharm Biomed Anal 47(4-5): 899-906.
Smitha P, Pore Y V, Kuchekar B S and Khire V G (2009) Determination of Montelukast Sodium and Bambuterol Hydrochloride tablets using RP-HPLC. Ind J Pharm Sci 71(1): 58-61.
Alireza S, Afshin Z, Seyed M (2010) Rapid and sensitive determination of Montelukast in human plasma by HPLC method using monolithic column application to pharmacokinetic studies. J Bioequi Availab 2(06): 135-138.
Shaiba N, Devi K, Prashanthi R, Raghavi K and Sindhura M (2011) High performance thin layer chromatographic estimation of Rupatadine Fumarate. Res J Pharm Tech 4(3): 420-422.
Sane R T, Ajai M, Mandar M, Gunesh G (2004) HPTLC Determination of Montelukast Sodium in bulk drug and its pharmaceutical preparations. J Pharm Chem 17(1): 75-78.
Jun W, Zhanying H, Hua W, Guorong F (2009) Simultaneous determination of Rupatadine and its metabolite desloratadine in human plasma by a sensitive LCMS/MS method Application to the pharmacokinetic study in healthy Chinese volunteers. J Pharm Biomed Anal 49(2): 347-353.
Daniele R N, Maximilianoda S S and Vitor T (2008) Determination of Rupatadine in pharmaceutical formulation by a validated stability – indicating method. J Sep Sci 31(17): 3098-3105.
Shakalisava Y and Ragan F (2008) Determination of Montelukast Sodium by capillary electrophoresis. J Sep Sci 31(17): 1137-1143.
ICH (1996) Proceedings of the International Conference on Harmonisation of Technical Requirement of Registration of Pharmaceutical for Human Use (ICH Harmonised Tripartite Guidelines). Validation of Analytical Procedures: Methodology, Q2R1, Geneva, Switzerland.