Simultaneous analysis of atorvastatin calcium and losartan potassium in tablet dosage forms by RP-HPLC and HPTLC

• Autorzy: Panchal H. J , Suhagia B. N
• Języki publikacji: EN

Abstrakty

EN

Two simple and accurate reversed-phase high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC) methods for simultaneous determination of atorvastatin calcium and losartan potassium in tablet dosage forms have been established and validated. The HPLC separation was achieved on a Phenomenex Luna C 18 column (250 mm, 4.6 mm i.d., 5 μm) with 0.05 M potassium dihydrogen phosphate buffer (pH 5.4)-acetonitrile 45:55 (%, v / v ) as isocratic mobile phase at a flow rate of 1 mL min ^-1. The retention times were approximately 7.56 and 3.73 min for atorvastatin calcium and losartan potassium, respectively. Quantification was achieved at 238 nm with a photodiode-array (PDA) detector over the concentration range 0.5–5 μg mL ^-1, for each compound, with mean recoveries of 100.67 ± 0.58 and 100.51 ± 0.63% for atorvastatin calcium and losartan potassium, respectively. The HPTLC separation was achieved on silica gel 60 F254 HPTLC plates with methanol-carbon tetrachloride-ethyl acetate-glacial acetic acid 8:63.6:28:0.4 ( v / v ) as mobile phase. The retardation factors ( R F ) were approximately 0.45 and 0.30 for atorvastatin calcium and losartan potassium, respectively. Quantification was achieved by ultraviolet (UV) detection at 238 nm over the concentration range of 50–500 ng band ^-1 for each, with mean recoveries of 100.59 ± 0.47 and 100.48 ± 0.81% for atorvastatin calcium and losartan potassium, respectively. Both methods were validated, and the results were compared statistically by use of a paired t -test. The methods were found to be simple, specific, accurate, precise, and robust, and were successfully used for analysis of the drugs in tablet dosage forms without interference from common excipients.

Słowa kluczowe

EN

reversed-phase high-performance liquid chromatography (RP-HPLC); highperformance thin-layer chromatography (HPTLC); atorvastatin calcium; losartan potassium; tablet dosage forms

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2010
• Tom: Vol. 22, no. 2
• Strony: 173--187
• Opis fizyczny: Bibliogr. 36 poz., rys., tab.

Twórcy

autor

Panchal H. J

• Shree S.K. Patel College of Pharmaceutical Education and Research Ganpat Vidyanagar, Kherva, Mehsana 382711 Gujarat India

autor

Suhagia B. N

• L.M. College of Pharmacy Department of Pharmaceutical Chemistry Navrangpura, Ahmedabad 380009 Gujarat India

Bibliografia

• [1] H.S. Malhotra and K.L. Goa, Drugs, 61 , 1835–1881 (2001)
• [2] Martindale: The complete dug reference, 35th edn, The Pharmaceutical Press, London, 2007, p. 866
• [3] L. Mazzolai and M. Burnier, Drugs Saf., 21 , 23–33 (1999)
• [4] E. Nevin, Anal. Lett., 36 , 2699–2711 (2003)
• [5] V. Nagaraj, V. Kalamkar, and R. Mashru, Anal. Sci., 2 , 445–451 (2007)
• [6] R. Sahu and B.P. Vandana, Indian J. Pharm. Sci., 69 , 110–111 (2007)
• [7] B.G. Chaudhari, N.M. Patel, P.B. Shah, and K.P. Modi, Indian J. Pharm. Sci., 68 , 793–796 (2006)
• [8] S.S. Yadav, D.V. Mhaske, A.B. Kakad, B.D. Patil, S.S. Kadam, and S.R. Dhaneshwar, Indian J. Pharm. Sci., 67 , 182–188 (2005)
• [9] A. Jamshidi and A.R. Nateghi, Chromatographia, 65 , 763–766 (2007)
• [10] G. Bahrami, B. Mohammadi, S. Mirzaeei, and A. Kiani, J. Chromatogr. B, 826 , 41–45 (2005)
• [11] S. Erturk, A.E. Sevinc, L. Ersoy, and S. Ficicioglu, J. Pharm. Biomed. Anal. 33 , 1017–1023 (2003)
• [12] D.A. Shah, K.K. Bhatt, M.B. Shankar, R.S. Mehta, T.R. Gandhi, and S.L. Baldania, Indian J. Pharm. Sci., 68 , 796–799 (2006)
• [13] K.R. Rajeswari, G.G. Sankar, A.L. Rao, and J.V. Seshagirirao, Indian J. Pharm. Sci., 68 , 275–277 (2006)
• [14] B.G. Chaudhari, N.M. Patel, and P.B. Shah, Chem. Pharm. Bull., 55 , 241–246 (2007)
• [15] A. Mohammadi, N. Rezanour, D.M. Ansari, B.F. Ghorbani, M. Hashem, and R.B. Walker, J. Chromatogr. B, 846 , 215–221 (2007)
• [16] B.G. Chaudhari, N.M. Patel, P.B. Shah, L.J. Patel, and V.P. Patel, J. AOAC, 90 , 1539–1546 (2007)
• [17] K. Alla, J. AOAC, 90 , 1547–1553 (2007)
• [18] B.V. Dohalsky, J. Huclova, B. Barrett, B. Nemec, I. Ulc, and D.I. Jelinek, Anal. Bioanal. Chem., 386 , 275–285 (2006)
• [19] M. Hermann, H. Christensen, and J.L.E. Reubsaet, Anal. Bioanal. Chem. 382 , 1242–1249 (2005)
• [20] L. Ma, J. Dong, X.J. Chen, and G.J. Wang, Chromatographia, 65 , 737–741 (2007)
• [21] O.C. Lastra, I.G. Lemus, H.J. Sánchez, and R.F. Perez, J. Pharm. Biomed. Anal., 33 , 175–180 (2003)
• [22] E. Nevin, J. Pharm. Biomed. Anal., 24 , 603–611 (2001)
• [23] S.A. Shah, I.S. Rathod, B.N. Suhagia, S.S. Savle, and J.B. Patel, J. AOAC, 84 , 1715–1723 (2001)
• [24] T.W. Inglot, K. Dąbrowska, and G. Misztal, J. Planar Chromatogr., 20 , 293–301 (2007)
• [25] L. Maja, C. Tanja, T. Jadranka, P. Marijana, P. Lidija, and M. Nenad, Int. J. Pharm., 291 , 127–137 (2005)
• [26] K.E. McCarthy, Q. Wang, E.W. Tsai, R.E. Gilbert, and M.A. Brooks, J. Pharm. Biomed. Anal., 17 , 671–677 (1998)
• [27] T. Sivakumar, P. Venkatesan, R. Manavalan, and K. Valliappan, Indian J. Pharm. Sci., 69 , 154–157 (2007)
• [28] M. Ansari, M. Kazemipour, F. Khosravi, and M.A. Baradaran, Chem. Pharm. Bull., 52 , 1166–1170 (2004)
• [29] B.N. Suhagia, R.R. Shah, and D.M. Patel, Indian J. Pharm. Sci., 67 , 37–42 (2005)
• [30] E. Dinc and O. Ustunda, Chromatographia, 61 , 237–244 (2005)
• [31] J.J.I. Tamimi, I.I. Salem, A.S. Mahmood, Q. Zaman, and D. Ruwayda, Biopharm. Drug Dispos., 26 , 205–210 (2005)
• [32] D.L. Hertzog, J.F. McCafferty, X. Fang, R.J. Tyrrell, and R.A. Reed, J. Pharm. Biomed. Anal., 30 , 747–760 (2002)
• [33] P.K. Yeung, A. Jamieson, G.J. Smith, D. Fice, and P.T. Pollak, Int. J. Pharm., 204 , 17–22 (2000)
• [34] Z. Zhongxi, W. Qingxi, W.T. Eric, Q. Xue-Zhi, and I.P. Dominic, J. Pharm. Biomed. Anal. 20 , 129–136 (1999)
• [35] H. Lee, H.O. Shim, and H.S. Lee, Chromatographia, 42 , 39–42 (1996)
• [36] Validation of Analytical Procedures: Text and Methodology Q2(R1), International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, 2005