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HPLC Method for Simultaneous Analysis of Ranitidine and Metronidazole in Dosage Forms
Asian Journal of Chemistry,
Vol. 26 No. 2 (2014): Vol 26 Issue 2
Abstract
A simple, rapid, precise and accurate stability indicating HPLC method for the simultaneous analysis of metronidazole and ranitidine in dosage forms has been developed and validated. Calibration curves for metronidazole and ranitidine exhibited linearity (R2 = 0.9995 for both compounds) over the concentration ranges investigated. The method was sensitive, selective and accurate for both compounds. Both drugs were found to be stable following acid hydrolysis studies. However, following alkali hydrolysis degradation of both compounds was observed. Furthermore metronidazole appeared to be stable following oxidative studies however ranitidine underwent complete degradation under these conditions. Both drugs were well resolved from the degradation products. The stability indicating chromatographic method has the necessary precision and accuracy for the simultaneous analysis of metronidazole and ranitidine in dosage forms.
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- R.L. Snyder, J.J. Kirkland and W.J. Dolan, Introduction to Modern Liquid Chromatography, John Wiley & Sons, United States of America, edn 3, Vol. 1 (2010)..
- T.G. do Nascimento, E. de Jesus Oliveira and R.O. Macédo, J. Pharm. Biomed. Anal., 37, 777 (2005); doi:10.1016/j.jpba.2004.11.042.
- J.S. Munro and T.A. Walker, J. Chromatogr. A, 914, 13 (2001); doi:10.1016/S0021-9673(01)00540-4.
- G.A. Shabir, J. Chromatogr. A, 987, 57 (2003); doi:10.1016/S0021-9673(02)01536-4.
- C. Flores Pérez, H. Juárez Olguín, J. Flores Pérez, A. Toledo López, I. Lares Asseff and C. Alvarez García, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 795, 141 (2003); doi:10.1016/S1570-0232(03)00474-4.
- G. Lunn and R.N. Schmuff, Ranitidine: In HPLC Methods for Pharmaceutical Analysis John Wiley & Sons, United States of America, p. 1209 (2000)..
- M. Bakshi, B. Singh, A. Singh and S. Singh, J. Pharmaceut. Biomed.Anal., 26, 891 (2001); doi:10.1016/S0731-7085(01)00475-7.
- G. Lunn, Metronidazole: In HPLC Methods for Pharmaceutical Analysis John Wiley & Sons, United States of America, pp. 1354-1362 (2000).
- R.B. Shah, P.R. Hullahalli, M.A. Tawakkul, P.J. Faustino, A. Nguyenpho and M.A. Khan, Clin. Res. Regul. Aff., 23, 35 (2006); doi:10.1080/10601330500545556.
- M. Bakshi and S. Singh, Pharm. Technol., 27, 148 (2003).
- K.I. Baren, Drugs of Acid Related Disorders. In South Africa Medicine Formulary, 8th[A02], Health and Medical Publishing Group: Cape Town, pp. 39-44 (2008).
- J.Q. Huang and R.H. Hunt, Best Pract. Res.Cl. Ga., 15, 355 (2001); doi:10.1053/bega.2001.0184.
- D. Clark and J. Strandell, Eur. J. Clin. Pharmacol., 62, 473 (2006); doi:10.1007/s00228-006-0131-1.
- S. Dial, J.A. Delaney, A.N. Barkun and S. Suissa, JAMA, 294, 2989 (2005); doi:10.1001/jama.294.23.2989.
- C. Scarpignato, Drug Discov. Today Ther. Strateg., 4, 155 (2007); doi:10.1016/j.ddstr.2007.09.003.
- J.P. Gisbert, L. Gonzalez, X. Calvet, M. Roque, R. Gabriel and J.M. Pajares, Aliment. Pharmacol. Ther., 15, 917 (2001); doi:10.1046/j.1365-2036.2001.01012.x.
- M.S. Khuroo, K.L. Farhat and I.E. Kageyi, Gastroenterol. Hepatol., 20, 11 (2005).
- Sung, Leung, Ling, Yung, Chan, Lee, Cheng and Chung, Aliment. Pharmacol. Ther., 12, 725 (1998); doi:10.1046/j.1365-2036.1998.00367.x.
- C. Melikian, T.J. White, A. Vanderplas, C.M. Dezii and E. Chang, Clin. Ther., 24, 460 (2002); doi:10.1016/S0149-2918(02)85047-0.
- R.L. Snyder, J.J. Kirkland and L.J. Glajch, Practical HPLC Method Development., John Wiley and Sons, USA, edn 2 (1997)..
- M. Bakshi and S. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002); doi:10.1016/S0731-7085(02)00047-X.
References
R.L. Snyder, J.J. Kirkland and W.J. Dolan, Introduction to Modern Liquid Chromatography, John Wiley & Sons, United States of America, edn 3, Vol. 1 (2010)..
T.G. do Nascimento, E. de Jesus Oliveira and R.O. Macédo, J. Pharm. Biomed. Anal., 37, 777 (2005); doi:10.1016/j.jpba.2004.11.042.
J.S. Munro and T.A. Walker, J. Chromatogr. A, 914, 13 (2001); doi:10.1016/S0021-9673(01)00540-4.
G.A. Shabir, J. Chromatogr. A, 987, 57 (2003); doi:10.1016/S0021-9673(02)01536-4.
C. Flores Pérez, H. Juárez Olguín, J. Flores Pérez, A. Toledo López, I. Lares Asseff and C. Alvarez García, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 795, 141 (2003); doi:10.1016/S1570-0232(03)00474-4.
G. Lunn and R.N. Schmuff, Ranitidine: In HPLC Methods for Pharmaceutical Analysis John Wiley & Sons, United States of America, p. 1209 (2000)..
M. Bakshi, B. Singh, A. Singh and S. Singh, J. Pharmaceut. Biomed.Anal., 26, 891 (2001); doi:10.1016/S0731-7085(01)00475-7.
G. Lunn, Metronidazole: In HPLC Methods for Pharmaceutical Analysis John Wiley & Sons, United States of America, pp. 1354-1362 (2000).
R.B. Shah, P.R. Hullahalli, M.A. Tawakkul, P.J. Faustino, A. Nguyenpho and M.A. Khan, Clin. Res. Regul. Aff., 23, 35 (2006); doi:10.1080/10601330500545556.
M. Bakshi and S. Singh, Pharm. Technol., 27, 148 (2003).
K.I. Baren, Drugs of Acid Related Disorders. In South Africa Medicine Formulary, 8th[A02], Health and Medical Publishing Group: Cape Town, pp. 39-44 (2008).
J.Q. Huang and R.H. Hunt, Best Pract. Res.Cl. Ga., 15, 355 (2001); doi:10.1053/bega.2001.0184.
D. Clark and J. Strandell, Eur. J. Clin. Pharmacol., 62, 473 (2006); doi:10.1007/s00228-006-0131-1.
S. Dial, J.A. Delaney, A.N. Barkun and S. Suissa, JAMA, 294, 2989 (2005); doi:10.1001/jama.294.23.2989.
C. Scarpignato, Drug Discov. Today Ther. Strateg., 4, 155 (2007); doi:10.1016/j.ddstr.2007.09.003.
J.P. Gisbert, L. Gonzalez, X. Calvet, M. Roque, R. Gabriel and J.M. Pajares, Aliment. Pharmacol. Ther., 15, 917 (2001); doi:10.1046/j.1365-2036.2001.01012.x.
M.S. Khuroo, K.L. Farhat and I.E. Kageyi, Gastroenterol. Hepatol., 20, 11 (2005).
Sung, Leung, Ling, Yung, Chan, Lee, Cheng and Chung, Aliment. Pharmacol. Ther., 12, 725 (1998); doi:10.1046/j.1365-2036.1998.00367.x.
C. Melikian, T.J. White, A. Vanderplas, C.M. Dezii and E. Chang, Clin. Ther., 24, 460 (2002); doi:10.1016/S0149-2918(02)85047-0.
R.L. Snyder, J.J. Kirkland and L.J. Glajch, Practical HPLC Method Development., John Wiley and Sons, USA, edn 2 (1997)..
M. Bakshi and S. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002); doi:10.1016/S0731-7085(02)00047-X.