Validated RP-HPLC method for the simultaneous determination of amlodipine besylate, valsartan, and hydrochlorothiazide in bulk and in pharmaceutical formulation

• Autorzy: Anandakumar K , Jothieswari D , Subathrai R , Santhi D. V , Vetrichelvan T
• Języki publikacji: EN

Abstrakty

EN

A reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of amlodipine besylate (AMB), valsartan (VAL), and hydrochlorothiazide (HCT) in pharmaceutical formulation using RP-C18 column. The mobile phase (acetonitrile:methanol:50 mM phosphate buffer adjusted to pH 3 with orthophosphoric acid) was pumped at a flow rate of 1.0 mL min^-1 in the ratio of 20:50:30% v/v and the eluents were monitored at 239 nm. Linearity was obtained in the concentration range of 0.5–5 μg mL^-1 for AMB, 4–40 μg mL^-1 for VAL, and 1–10 μg mL^-1 for HCT. The method was validated as per International Conference on Harmonization (ICH) guidelines and statistically. The method was validated for accuracy and precision. For precision, the coefficient of variance (COV) was found to be 0.3794, 0.1703 and 0.0578, and for accuracy, it was found to be 0.6351, 0.7688 and 1.1305 for AMB, VAL, and HCT, respectively. The COV values for all the drugs were found to be less than 2%, indicating high degree of precision and accuracy of the proposed high-performance liquid chromatographic (HPLC) method. Owing to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method can be applied for determining AMB, VAL, and HCT in bulk and in pharmaceutical dosage form.

Słowa kluczowe

EN

amlodipine besylate; valsartan; hydrochlorothiazide; RP-HPLC

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2012
• Tom: Vol. 24, no. 1
• Strony: 37--50
• Opis fizyczny: Bibliogr. 36 poz., rys., tab.

Twórcy

autor

Anandakumar K

• Adhiparasakthi College of Pharmacy Department of Pharmaceutical Analysis Melmaruvathur 603 319 Tamil Nadu India

autor

Jothieswari D

• Adhiparasakthi College of Pharmacy Department of Pharmaceutical Analysis Melmaruvathur 603 319 Tamil Nadu India

autor

Subathrai R

• Adhiparasakthi College of Pharmacy Department of Pharmaceutical Analysis Melmaruvathur 603 319 Tamil Nadu India

autor

Santhi D. V

• Adhiparasakthi College of Pharmacy Department of Pharmaceutical Analysis Melmaruvathur 603 319 Tamil Nadu India

autor

Vetrichelvan T

• Adhiparasakthi College of Pharmacy Department of Pharmaceutical Analysis Melmaruvathur 603 319 Tamil Nadu India

Bibliografia

• [1] S. Budavari, The Merck Index, An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edn, Merck Research Lab, Division of Merck & Co., Inc., Whitehouse Station, NJ, 2006, pp. 83
• [2] P. Rathee, S. Rathee, S. Thakur, and V. Kumar, Int. J. Chem. Tech. Res., 2, 62 (2010)
• [3] N.M. Bhatia, S.J. Deshmane, H.N. More, and P.B. Choudhari, Asian J. Res. Chem., 2, 393 (2009)
• [4] P. Salve, D. Gharge, R. Kirtawade, P. Dhabale, and K. Burade, Asian J. Res. Chem., 2, 553 (2009)
• [5] P.R. Patil, S.U. Rakesh, P.N. Dhabale, and K.B. Burade, Int. J. Chem. Tech. Res., 1, 464 (2009)
• [6] European Pharmacopoeia, 3rd edn, Council of Europe, Strasbourg, 2001, pp. 431
• [7] V.J. Dhorda and N.B. Shetkar, Indian Drugs, 36, 638 (1999)
• [8] V.G. Dongre, S.B. Shah, P.P. Karmuse, M. Phadke, and V.K. Jadhav, J. Pharm. Biomed. Anal., 46, 583 (2008)
• [9] K. Ilango, P.B. Kumar, and V.R.V. Prasad, Indian J. Pharm. Sci., 59, 171 (1997)
• [10] Y. Feng, L. Zhang, Z. Shen, F. Pan, and Z. Zhang, J. Chromatogr. Sci., 40, 49 (2002)
• [11] A.P. Agrekar and S.G. Powar, J. Pharm. Biomed. Anal., 21, 1137 (2000)
• [12] J. Bhatt, S. Singh, G. Subbaiah, B. Shah, S. Kambli, and S. Ameta, J. Biomed. Chromatogr., 21, 169 (2007)
• [13] http://www.rxlist.com/exforge-hct-drug.htm
• [14] Goodman and Gillman’s, The Pharmacological Basis of Therapeutics, 10th edn, McGraw Hill Medical Publishing Division, New York, 2001, pp. 894
• [15] K.B. Kocyigit, S. Unsalan, and S. Rollas, Pharmazie, 61, 586 (2006)
• [16] N. Daneshtalab, R.Z. Lewanczuk, and F. Jamali, J. Chromatogr. B. Analyt. Technol. Biomed. Life Sci., 766, 345 (2002)
• [17] L. Gonzalez, J.A. Lopez, R.M. Alonso, and R.M. Jimenez, J. Chromatogr. A, 949, 49 (2002)
• [18] N. Koseki, H. Kawashita, H. Hara, M. Niina, M. Tanaka, R. Kawai, Y. Nagae, and N. Masuda, J. Pharm. Biomed. Anal., 43, 1769 (2007)
• [19] H. Li, Y. Wang, Y. Jiang, Y. Tang, J. Wang, L. Zhao, and J. Gu, J. Chromatogr. B. Analyt. Technol. Biomed. Life Sci., 852, 436 (2007)
• [20] S.P. Senthamil, V.K. Gowda, U. Mandal, W.D. Solomon, and T.K. Pal, J. Chromatogr. B. Analyt. Technol. Biomed. Life Sci., 858, 143 (2007)
• [21] J. Macek, J. Klima, and P. Ptacek, J. Chromatogr. B. Analyt. Technol. Biomed. Life Sci., 832, 169 (2006)
• [22] S. Hillaert and V.W. Bossche, J. Pharm. Biomed. Anal., 31, 329 (2003)
• [23] E. Satana, S. Altinay, N.G. Goger, S.A. Ozkan, and Z.J. Senturk, J. Pharm. Biomed. Anal., 25, 1009 (2001)
• [24] S. Tatar and S. Saglik, J. Pharm. Biomed. Anal., 30, 371 (2002)
• [25] S. Budavari, The Merck Index, An Encyclopedia of Chemical, Drugs, and Biologicals, 14th edn, Merck Research Lab, Division of Merck & Co., Inc., Whitehouse Station, NJ, 2006, pp. 827
• [26] S.L. Daniels and A.J. Vanderwielen, J. Pharm. Sci., 70, 211 (2006)
• [27] D. Tian, X. Tian, T. Tian, Z. Wang, and F. Mo, Indian J. Pharm. Sci., 70, 372 (2008)
• [28] M.M. Baing, V.V. Vaidya, R.T. Sane, S.N. Menon, and K. Dalvi, Chromatographia, 64, 293 (2006)
• [29] K. P. Bhusari, P.B. Khedekar, S. Dhole, and V.S. Banode, Indian J. Pharm. Sci., 71, 505 (2009)
• [30] M. Stolarczyk, A. Maslanka, J. Krzek, and J. Milczarek, Acta Poloniae Pharm. Drug Res., 65, 275 (2008)
• [31] T. Huang, Z. He, B. Yang, L. Shao, X. Zheng, and G. Duan, J. Pharm. Biomed. Anal., 41, 644 (2006)
• [32] United States Pharmacopoeia, 27th edn, United States Pharmacopoeial Convention, Washington DC, 2009, pp. 1532, 2566, 3842
• [33] The Indian Pharmacopoeia, Vol. II, Government of India, Ministry of Health and Family Welfare, Published by the Controller of Publication, New Delhi, 2007, pp. 714, 318
• [34] British Pharmacopoeia, Vol. I, international edn, Vol. I, Her Majesty’s Stationary Office, London, 2009, pp. 137, 565
• [35] International Conference on Harmonization (ICH), Q2A: Text on Validation of Analytical Procedures: Definitions and Terminology, Vol. 60, US FDA Federal Register, 1995
• [36] International Conference on Harmonization (ICH), Q2B: Validation of Analytical Procedures: Methodology, Vol. 62, US FDA Federal Register, 1997