Back
 AJAC  Vol.6 No.8 , July 2015
Method Development and Validation for Simultaneous Estimation of Montelukast Sodium and Desloratadine by RP-HPLC
Abstract: A novel, precise, accurate, rapid and cost effective isocratic reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the simultaneous estimation of Montelukast Sodium (MON) and Desloratadine (DES) in pharmaceutical dosage forms. The drugs were estimated using Hypersil BDS C18 (250 mm × 4.6 mm I.D., 5 μ particle size) column. The mobile phase composed of orthophosphoric acid and water in the ratio of 20:80 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 280 nm. The linearity range obtained was 10 - 30 μg/ml for MON and 5 - 15 μg/ml for DES with retention times of 2.929 min and 4.439 min for MON and DES respectively. The correlation coefficient values were found to be 0.999. Precision studies showed % RSD values less than 2% for both the drugs in all the selected concentrations. The percentage recoveries of MON and DES were in the range of 99.59% - 99.82% and 99.60% - 99.80% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.176 μg/ml, 0.587 μg/ml for MON and 0.087 μg/ml, 0.292 μg/ml for DES respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available tablet dosage forms.
Cite this paper: Gandhi, B. , Rao, A. and Rao, J. (2015) Method Development and Validation for Simultaneous Estimation of Montelukast Sodium and Desloratadine by RP-HPLC. American Journal of Analytical Chemistry, 6, 651-658. doi: 10.4236/ajac.2015.68063.
References

[1]   Government of India (2014) Indian Pharmacopoeia, Volume II. Ministry of Health and Family Welfare, The Indian Pharmacopoeia Commission, Ghaziabad, 2247 (Montelukast).

[2]   Jarvis, B. and Markham, A. (2000) Montelukast. Drugs, 59, 891-928.
http://dx.doi.org/10.2165/00003495-200059040-00015

[3]   Neil, O.J.M. (2006) The Merck Index: An Encyclopedia of Chemicals Drug and Biologicals. 14th Edition, Merck Research Laboratories, Division of Merck and Co. Inc., White House Station, NJ, 1080 (Montelukast) & 496 (Desloratadine).

[4]   Murdoch, D., Goa, K.L. and Keam, S.J. (2003) Desloratadine. Drugs, 63, 2051-2077.
http://dx.doi.org/10.2165/00003495-200363190-00010

[5]   Sweetman, S.C. (2011) Martindale: The Complete Drug Reference, Volume A. 37th Edition, Pharmaceutical Press, London, 1240 (Montelukast) & 626 (Desloratadine).

[6]   CIMS (Current Index of Medical Specialities) (2015) UBM Medica India Pvt. Limited, Bangalore, Jan-April, 453 (Montelukast) & 450 (Desloratadine).

[7]   IDR Drug Triple i Compendium (Indian Drug Review) (2015) UBM Medica India Pvt. Limited, Bangalore, 2, 53 (Montelukast) & 217 (Desloratadine).

[8]   Davis, B.E., Todd, D.C. and Cockcroft, D.W. (2005) Effect of Combined Montelukast and Desloratadine on the Early Asthmatic Response to Inhaled Allergen. Journal of Allergy and Clinical Immunology, 116, 768-772.
http://dx.doi.org/10.1016/j.jaci.2005.06.014

[9]   Patel, S.V., Patel, G.F. and Pipaliya, S.G. (2012) Derivative Spectroscopic Method for Simultaneous Estimation of Montelukast Sodium and Desloratadine in Bulk and Combined Dosage Form. Inventi Imapct: Pharmaceutical Analysis and Quality Assurance, 2, 82-85.

[10]   Rima, M.B. and Dipti, B.P. (2013) Simultaneous Estimation of Montelukast Sodium and Desloratadine by Ratio Spectra Derivative Spectrophotometry Method in Combined Dosage Forms. Journal of Chemical and Pharmaceutical Research, 5, 193-199.

[11]   Jain, R.R., Patil, P.O. and Bari, S.B. (2013) Simultaneous Estimation of Montelukast Sodium and Desloratadine in Bulk and in Tablet Formulation by UV Spectrophotometry. Indian Drugs, 50, 30-35.

[12]   Rima, M.B. and Dipti, B.P. (2013) RP-HPLC Method for Simultaneous Estimation of Montelukast Sodium and Desloratadine in Combined Dosage Form. Article ID: PHARMATUTOR-ART-1735.

[13]   Vibhuti, R.C. and Jitendra, P. (2012) Simultaneous Estimation of Montelukast Sodium and Desloratadine by RP-HPLC in their Marketed Formulation. International Journal of Chem Tech Research, 4, 1402-1407.

[14]   Kalyankar, T.K., Kokate, R.H. and Kakade, R.B. (2012) RP-HPLC Method for Simultaenous Estimation of Montelukast Sodium and Desloratadine from Bulk and Tablets Formulation. International Research Journal of Pharmacy, 3, 343-347.

[15]   Mallesham, B., Geetha, K., Uma Maheswar Rao, V. and Rama Rao, N. (2014) Simultaneous Estimation of Desloratadine and Montelukast in Bulk and Pharmaceutical Formulations by RP-HPLC. International Journal of Innovative Technology and Research, 2, 1181-1186.

[16]   ICH Harmonised Tripartite Guideline (2011) Validation of Analytical Procedures: Text and Methodology, Q2(R1), Geneva, 1-13.

 
 
Top