Asian Journal of Research in Chemistry

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Derivative Spectrophotometric Method for Simultaneous Estimation of Montelukast Sodium and Ebastine in Bulk and Their Combined Tablet Dosage Form


Affiliations
1 Parul Institute of Pharmacy, Waghodia, Limda, Gujarat, India
2 Parul Institute of Pharmacy and Research, Waghodia, Limda, Gujarat, India
     

   Subscribe/Renew Journal


Simple spectrophotometric methods have been developed for simultaneous estimation of Montelukast Sodium and Ebastine from tablet dosage form. First order derivative Method in which absorbance is measured at two wavelengths, 364 nm at which involves two zero crossing points, 256.5 nm (for measurement of Ebastine) and 364 nm (for measurement of Montelukast Sodium). Both the methods were found linear between the range of 5-25 µg/ml for Both drugs . The accuracy and precision were determined and found to comply with ICH guidelines. Both the methods showed good reproducibility and recovery with % RSD in the desired range. The methods were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of Montelukast Sodium and Ebastine in their combined tablet dosage form.

Keywords

Montelukast Sodium, Ebastine, Simultaneous Equation Method, Absorbance Correction Method
Subscription Login to verify subscription
User
Notifications
Font Size


  • In-process Revision Pharmacopeial Forum The United States Pharmacopeial Convention. 2010; 36(1).

  • The merck index. Merck Research laboratories. 2006; 14th ed: pp. 591,1081.

  • Rang HP, Dale MM, Ritter JN, Moore PK. Pharmacology. Churchill Livingstone. Elsevier Science Ltd. 2008; 6th ed: pp. 361-63.

  • Satoskar RS, Bhandarkar SD. Pharmacology and Pharmacotherapeutics. Popular prakashan. 2008; 20th ed: pp.357- 58.

  • Tripathi KD. Essential of medical pharmacology. Jaypee Brothers Ltd. 2008; 6th ed: pp.222-23.

  • Indian Pharmacopoeia. Volume 2. The Indian Pharmacopoeia Commission, Ghaziabad, Govt. of India Ministry of Health and Family Welfare; 2010. pp. 1704-1706.

  • http://www.chemicalbook.com/ProductChemicalPropertiesCB82 71800_EN.htm

  • British Pharmacopoeia. Department of Health; Published by the stationery Office on behalf of the medicines and Healthcare products Regulatory Agency (MHRA); Volume I , London, HMSO Publication ;2009. pp. 735

  • Patel DJ, Patel SA, Patel SK. Simultaneous determination of Montelukast sodium and Bambuterol hydrochloride in tablet dosage form by ultraviolet spectrophotometry (Dual wavelength method). International Journal on Pharmaceutical and Biomedical Research. 2010; 1(3): 71-75.

  • Pawar V, Pai1 S and Roa GK. Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Montelukast Sodium and Bambuterol Hydrochloride in Bulk and Tablet Dosage Formulation. Jordan Journal of Pharmceutical Science. 2008; 1(2): 152-158.

  • Kamyar P, Zahra MK, Alireza G, Mahmoud RS, Hossein A. Spectrophotometric Determination Of Cetirizine And Montelukast In Prepared Formulations. International Journal of Pharmacy and Pharmaceutical Science. 2011; 3(2): 128-130.

  • Chavda RS, Vaghela JP, Patel PB, Shah JS. uv spectrophotometic methods for simultaneous estimation of montelukast sodium and desloratadinein combined tablet dosage form. Pharm Analysis & Quality Assurance.2012: 412-416.

  • Patel SV, Patel GF, Pipaliya SG. Development and validation of derivative spectroscopic method for simultaneous estimation of montelukast sodium and desloratadine in bulk and combined dosage form. Pharm Analysis & Quality Assurance.2012.

  • Patel NK and Pancholi SS. Spectrophotometric Determination of Montelukast Sodium and Levocetirizine Dihydrochloride in Tablet Dosage Form by AUC Curve Method. Der Pharma Chemica. 2011; 3 (5): 135-140.

  • Patel PG, Vaghela VM, Rathi SG, Rajgor NB and Bhaskar VH. Derivative spectrophotometry method for simultaneous estimation of rupatadine and montelukast in their combined dosage form. Pharmaceutical analysis. 2009; 1(4): 354-358.

  • Soni L.K, Narsinghani T, Saxena C. Development and validation of UV Spectrophotometric assay protocol for simultaneous estimation of Ebastine and Phenylephrine Hydrochloride in tablet dosage form using simultaneous equation method. International Journal of ChemTech Research. 2011; 3(4):1918-1925.

  • Wagh RS, Hajare RA, Tated A and Chandewar AV. Absorption correction method and simultaneous equation method for the simultaneous estimation of ebastine and phenylephrine hydrochloride in bulk and in combined tablet dosage form. International Journal of Research in pharmacy and chemistry. 2011; 1(4): 812-818.

  • Singh RM, Saini PK, Mathur SC, Singh GN, and Lal B. Development and Validation of a RP-HPLC Method for Estimation of Montelukast Sodium in Bulk and in Tablet Dosage Form. Indian Journal Pharm Science. 2010; 72(2): 235–237.

  • Patil S, Pore YV, Kuchekar BS, Mane A, and Khire VG. Determination of Montelukast Sodium and Bambuterol Hydrochloride in Tablets using RP HPLC. Indian Journal Pharm Science. 2009; 71(1): 58–61.

  • Ravisankar M, uthirapathy S, Thangadurai A, and Dhanapal K. simultaneous estimation of Fexofenadine hydrocloride and Montelukast Sodium in bulk drug and marketed formulation by RP-HPLC method. International Research Journal of Pharmacy. 2012; 3(4): 356-359.

  • Eswarudua MM, Junapudia S, charya TN. RP-HPLC Method Development and Validation for Simultaneous Estimation of Montelukast Sodium and Levocetirizine Dihydrochloride in Tablet Dosage Form. International Journal of Pharma world Research 2011;2(4): 1-18.

  • Radhakrishna T , Narasaraju A , Ramakrishna M , Satyanarayana A. Simultaneous determination of montelukast and loratadine by HPLC and derivative spectrophotometric methods. Journal of Pharmceuitcal and Biomedical Analysis. 2003 ; 31: 359/368.

  • Wagh RS, Hajare RA, Tated AG, Gadbail PA, Khan RA, Kayal SD. Method development and validation for simultaneous estimation of Ebastine and Phenylephrine hydrochloride in tablet formulation by RP-HPLC. International Journal of pharmaceutical Research and Development. 2011; 3(7): 214- 220.

  • Prabu S.L., Dinesh C, Shirwaikar A, and Shirwaikar A. Determination of Ebastine in Pharmaceutical Formulations by HPLC. Indian Journal Pharmaceutical Science. 2008; 70(3): 406–407.

  • Chabukswar AR, Choudhari VP, Jagdale SC, Sharma SN, Bari NA, Pagare BD. Simultaneous Estimation of Montelukast Sodium and Fexofenadine HCL in Pharmaceutical Formulation by RP-LCPDA. International Journal of Pharmaceutical Science and Research. 2012; 2(1): 241-248.

  • Kang W, Liu KH, Ryu JY, and Shin JG. Simultaneous determination of ebastine and its three metabolites in plasma using liquid chromatography-tandem mass spectrometry. Journal of Chromatogram B. 2004; 813: 75-80.

  • Suparna ST, Snehal JM, Atul SR, Ajinkya RN, Lohidasan S., and Kakasaheb RM. 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. Analytical Chem. 2012.

  • Rathore AS, Sathiyanarayanan L, and 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. pharmaceutical analytica acta. 2010.

  • Rote, Ambadas, Niphade, Vaishali. determination of montelukast sodium and levocetirizine dihydrochloride in combined tablet dosage form by hptlc and first-derivative spectrophotometry. Journal of Liquid Chromatogram & Related Technology. 2011; 34(3): 155-167.

  • ICH, Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005.


Abstract Views: 508

PDF Views: 2




  • Derivative Spectrophotometric Method for Simultaneous Estimation of Montelukast Sodium and Ebastine in Bulk and Their Combined Tablet Dosage Form

Abstract Views: 508  |  PDF Views: 2

Authors

Nikesh S. Rana
Parul Institute of Pharmacy, Waghodia, Limda, Gujarat, India
K. S Rajesh
Parul Institute of Pharmacy, Waghodia, Limda, Gujarat, India
Nikita N. Patel
Parul Institute of Pharmacy, Waghodia, Limda, Gujarat, India
Ujjaval Limbachiya
Parul Institute of Pharmacy and Research, Waghodia, Limda, Gujarat, India

Abstract


Simple spectrophotometric methods have been developed for simultaneous estimation of Montelukast Sodium and Ebastine from tablet dosage form. First order derivative Method in which absorbance is measured at two wavelengths, 364 nm at which involves two zero crossing points, 256.5 nm (for measurement of Ebastine) and 364 nm (for measurement of Montelukast Sodium). Both the methods were found linear between the range of 5-25 µg/ml for Both drugs . The accuracy and precision were determined and found to comply with ICH guidelines. Both the methods showed good reproducibility and recovery with % RSD in the desired range. The methods were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of Montelukast Sodium and Ebastine in their combined tablet dosage form.

Keywords


Montelukast Sodium, Ebastine, Simultaneous Equation Method, Absorbance Correction Method

References