Development of a New UPLC Method for Simultaneous Determination of Valsartan, Amlodipine Besylate, and Hydrochlorothiazide Pharmaceutical Products

• Autorzy: Lahsini R. , Monser L.
• Języki publikacji: EN

Abstrakty

EN

A new ultra-performance liquid chromatography method for the simultaneous determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations has been developed. Chromatographic separation was achieved within 1 min on a sub-2 μm RP18 column using an isocratic mode mobile phase consisting of a mixture of methanol and phosphate buffer (0.05 M, pH 3 ± 0.05) in the ratio 70:30 (v/v). The flow rate was set at 0.3 mL min^-1 with a detection wavelength of 239 nm. The method was validated over the concentration ranges from 6.5 to 15.0 μg Ml ^-1 for hydrochlorothiazide, from 5.0 to 12 μg Ml^-1 for amlodipine besylate and from 76.5 to 178.5 μg Ml^-1 for valsartan. Calibration plots were linear for valsartan, amlodipine besylate, and hydrochlorothiazide with a correlation coefficient greater than 0.99. Relative variation coefficients for repeatability and reproducibility were less than 3.0%. Recoveries from standard addition essay of individual component in pharmaceutical formulations were varied from 97.0% to 102.0%. The proposed method was successfully applied for the determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations with recoveries with respect to label amount in pharmaceutical formulations that varied from 98.0% to 102.9%. The low flow rate, short analysis time, and simple mobile phase composition make the method cost effective, rapid, nontedious, and successfully employed for simultaneous determination of these drugs in commercial pharmaceutical products.

Słowa kluczowe

EN

UPLC; valsartan; amlodipine besylate; hydrochlorothiazide; pharmaceutical formulations

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2015
• Tom: Vol. 27, no. 3
• Strony: 449--460
• Opis fizyczny: Bibliogr. 22 poz., rys., tab.

Twórcy

autor

Lahsini R.

• Laboratory of Analytical and Electro-Chemistry, University of Carthage, National Institute of Applied Science and Technology, Centre Urbain Nord, B.P.N°676, 1080 Tunis Cedex, Tunisia

autor

Monser L.

• Laboratory of Analytical and Electro-Chemistry, University of Carthage, National Institute of Applied Science and Technology, Centre Urbain Nord, B.P.N°676, 1080 Tunis Cedex, Tunisia

Bibliografia

• [1] S. Budavari, The Merck Index, An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edn, Division of Merck and Co. Inc., USA, 2006
• [2] P. Rathee, S. Rathee, S. Thakur, and V. Kumar, Int. J. ChemTech Res., 2, 62 (2010)
• [3] N. Bhatia, S. Deshmane, H. More, and P. Choudhari, Asian J. Res. Chem., 2, 394 (2009)
• [4] P. Patil, S. Rakesh, P. Dhabale, and K. Burade, Int. J. ChemTech Res., 1, 464 (2009)
• [5] V. Dongre, S. Shah, P. Karmuse, M. Phadke, and V. Jadhav, J. Pharm. Biomed. Anal.,, 46, 583 (2008)
• [6] K. Ilango, P. Kumar, and V. Prasard, Indian J. Pharm. Sci., 59, 336 (1997)
• [7] Y. Feng, L. Zang, Z. Shen, F. Pan, and Z. Zhang, J. Chromatogr. Sci.,, 40, 49 (2002)
• [8] A. Agrekar and S. Pauer, J. Pharm. Biomed. Anal.,, 21, 1137 (2000)
• [9] J. Bhatt, S. Singh, G. Subbaiah, B. Shah, S. Kambli, and S. Ameta, Biomed. Chromatogr., 21, 169 (2007)
• [10] Goodman and Gillman's, The Pharmacological basis of Therapeutics, 10th edn, McGraw-Hill Medical Publishing Division, New York, 2001, pp. 894
• [11] K. Kocyigit, S. Unsalan and S. Rollas, Pharmazie, 61, 586 (2006)
• [12] L. Gonzalez, J. Lopez, R. Alonso, and R. Jiminez, J. Chromatogr. A., 949, 49 (2002)
• [13] N. Koseki, H. Kwashita, H. Hara, M. Nina, M. Tanaka, R. Kawai, Y. Nagae, and N. Masuda, J. Pharm. Biomed. Anal.,, 43, 1769 (2007)
• [14] P. Selvan, K. Gowda, U. Mandal, W. Solomon, and T. Pal, J. Chromatogr. B., 85, 269 (2007)
• [15] J. Macek, J. Clima, and P. Ptacek, J. Chromatogr. B., 755, 279 (2006)
• [16] S. Hillaert and V. Bossche, J. Pharm. Biomed. Anal.,, 31, 329 (2003)
• [17] E. Satana, S. Altinay, N. Gauger, S. Auzcan, and Z. J. Pharma. Biomed. Anal., 25, 1009 (2001)
• [18] S. Tatar and S. Saglik, J. Pharm. Biomed. Anal.,, 30, 371 (2002)
• [19] United States Pharmacopoeia, 27th edn, United States Pharmacopoeial Convention, Washington DC, 2009
• [20] The Indian Pharmacopoeia, Vol. II, Government of India, Ministry of Health and Family Welfare, published by the controller of publication, New Delhi, 2007
• [21] British Pharmacopoeia, Vol. I, international edition, London, 2009
• [22] International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline on Validation of Analytical Procedures: Methodology, adopted in 1996, Geneva