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Simultaneous Determination of Sodium, Potassium and Magnesium Counter Ions in Three Drugs: Pantoprazole Sodium, Losartan Potassium and Omeprazole Magnesium by Ion Chromatography
Corresponding Author(s) : Nagaraju Rajana
Asian Journal of Chemistry,
Vol. 30 No. 9 (2018): Vol 30 Issue 9
Abstract
The present analytical method was developed for single determination of three counter ions in pantoprazole sodium, losartan potassium and omeprazole magnesium drug substances by ion chromatography. The ion chromatography method was unique and suitable for three drugs such as pantoprazole sodium, losartan potassium and omeprazole magnesium with specification limits 5.7, 8.5 and 3.3 % of percentages of sodium, potassium and magnesium counter ions, respectively. The method was developed with Metrosep C4 (150 × 4.0 mm, 5 μ) column and combination of 4.0 mM nitric acid, 0.1 % dipicolinic acid and 10 % acetonitrile with flow of 1 mL. The injection volume used for this analysis was 20 μL with conductivity detector. The validation was performed to single ion chromatography method for three counter ions such as sodium in pantoprazole sodium, potassium in losartan potassium and magnesium in omeprazole magnesium. The % RSD for the method precision and intermediate of sodium in the pantoprazole sodium was 1.6 % and 1.6 %, respectively. The correlation coefficient for the linearity parameter of the sodium in the pantoprazole sodium was 1.000. The accuracy of sodium in pantoprazole sodium was observed as 97, 101 and 103 % recovery at 50, 100 and 150 %, respectively. The % RSD for the method precision and intermediate of potassium in the losartan potassium was 2.0 % and 1.5 %, respectively. The correlation coefficient for the linearity of the potassium in the losartan potassium was 0.999. The accuracy of potassium in losartan potassium was observed as 97.2, 100.0 and 101.8 % recovery at 50, 100 and 150 %, respectively. The % RSD for the method precision and intermediate precision of magnesium in the omeprazole magnesium was 1.7 and 2.0 %, respectively. The correlation coefficient for the linearity of the magnesium in the omeprazole magnesium was 1.000. The accuracy of magnesium in omeprazole magnesium was observed as 113.1, 98.5 and 98.5 % recovery at 50, 100 and 150 %, respectively. The robustness study was performed for flow of mobile phase from the actual flow and acetonitrile concentration. All the robustness values were less than the 10 % of initial counter ion content. The developed and validated method can be used for the simultaneous determination of sodium, potassium and magnesium counter ions in pantoprazole sodium, losartan potassium and omeprazole magnesium, respectively.
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- Q1A (R2) Stability Testing of New Drug Substances and Products.
- S. Goswami and P.K. Das, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 863, 9 (2008); https://doi.org/10.1016/j.jchromb.2007.12.016.
- Crystallineformofomeprazolesodiumsalt, https://patents.google.com/patent/DE69811892T2/en. https://patents.google.com/patent/WO2004037253A1/en.
- A.P. Micheel, C.Y. Ko and H.Y. Guh, J. Chromatogr. B Biomed. Sci. Appl., 709, 166 (1998); https://doi.org/10.1016/S0378-4347(98)00048-6.
- L. Gonzalez, J.A. Lopez, R.M. Alonso and R.M. Jimenez, J. Chromatogr. A, 949, 49 (2002); https://doi.org/10.1016/S0021-9673(01)01496-0.
- N. Ferreiros, G. Iriarte, R. Alonso and R. Jimenez, Talanta, 73, 748 (2007); https://doi.org/10.1016/j.talanta.2007.04.062.
- Indian Pharmacopoeia, Govt. of India, Ministry of Health and Family Welfare, Published by The Controller of Publications: New Delhi, vol. II (1996).
- J. Pentchuk, P. Alumaa, J. Ivask and M. Käärik, Proc. Estonian Acad. Sci. Chem., 54, 189 (2005).
- H. Small, Ion Chromatography, Plenum Press, New York (1989).
- J. Weiss, Ion Chromatography, VCH, Weinheim, edn 2 (1995).
- S. Schnell, S. Ratering and K. Jansen, Environ. Sci. Technol., 32, 1530 (1998); https://doi.org/10.1021/es970861g.
- USEPA Method, 300.7, Dissolved Sodium, Ammonium, Potassium, Magnesium and Calcium in Wet Depositionby Chemically Suppressed Ion Chromatography, USEPA, Cincinnati, OH, USA (1986).
- Australian Standard AS 3741-1990, Recommended Practice for Chemical Analysis by Ion Chromatography, Standards Australia, North Sydney, NSW (1990).
- K.A. Welch, W.B. Lyons, E. Graham, K. Neumann, J.M. Thomas and D. Mikesell, J. Chromatogr. A, 739, 257 (1996); https://doi.org/10.1016/0021-9673(96)00044-1.
- J. Ivask and J. Pentchuk, J. Chromatogr. A, 770, 125 (1997); https://doi.org/10.1016/S0021-9673(96)01084-9.
- N. Gros and B. Gorenc, J. Chromatogr. A, 789, 323 (1997); https://doi.org/10.1016/S0021-9673(97)00781-4.
- N. Gros and B. Gorenc, J. Chromatogr. A, 770, 119 (1997); https://doi.org/10.1016/S0021-9673(97)00060-5.
- D.A. Shah, A. Patel, S.L. Baldania, U.K. Chhalotiya and K.K. Bhatt, ISRN Spectrosc., Article ID 459820 (2013); https://doi.org/10.1155/2013/459820.
- S.S. Perumal, S.P. Ekambaram and S. Raja, J. Food Drug Anal., 22, 520 (2014); https://doi.org/10.1016/j.jfda.2014.05.003.
- K. Lakshmidurga, T.R.M. Reddy, A. Ajitha and V.U.M. Rao, J. Pharm. Chem., 8, 14 (2014).
- T.J. Chaudhary and S. Bhadani, Am. J. PharmTech Res., 3, 2249 (2013).
- G.A. Phadtare, S.C. Daswadkar and M.A. Kuchekar, Int. J. Appl. Pharm. Arch., 1, 92 (2016).
- S. Pandey, P. Pandey, D. Mishra and U.K. Singh, Braz. J. Pharm. Sci., 49, 175 (2013); https://doi.org/10.1590/S1984-82502013000100019.
- A. Kumar, M. Debnath, B. Vinod and J.V.L.N. Seshagiri Rao, Int. J. Pharmacol. Pharm. Sci., 3, 19 (2016).
- F Ali, G.N. Singh, P.L. Sahu, A. Prakash, M. Trivedi and T.A. Khan, World J. Pharm. Pharm. Sci., 4, 1145 (2015).
- S. Ashour and S. Omar, Arab. J. Chem., 9, S114 (2016); https://doi.org/10.1016/j.arabjc.2011.02.010.
- D. Bageshwar, V. Khanvilkar and V. Kadam, J. Pharm. Anal., 1, 275 (2011); https://doi.org/10.1016/j.jpha.2011.09.012.
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- S.U. Rakesh, P.R. Patil, P.N. Dhabale and K.B. Burade, J. Pharmacy Res., 2, 1252 (2009).
- M.S. Kishore and K.K. Kumar, Der Pharm. Chem., 6, 171 (2014).
- M. Stolarczyk, A. Maslanka, A. Apola and J. Krzek, Acta Pol. Pharm., 70, 967 (2013).
- H.M. Hafez, A.A. Elshanawane, L.M. Abdelaziz and M.M. Kamal, Iran. J. Pharm. Res., 12, 635 (2013).
- M.S. Kishore, K.K. Kumar, G. Ramu and C. Rambabu, Der Pharm. Lett., 7, 75 (2015).
- A. Farnoudian-Habibi, S. Kangari, B. Massoumi and M. Jaymand, RSC Adv., 5, 102895 (2015); https://doi.org/10.1039/C5RA20117A.
- S.V.S.G.B. Prasad, S. Shivakumar, T. Sudhir, R. Mital and G.D. Rao, Int. J. Pharm. Pharm. Sci., 1 (Suppl. 1), 206 (2009).
- B. Patel, M. Patel, J. Patel and B. Suhagiam, J. Liq. Chromatogr. Rel. Technol., 30, 1762 (2006); https://doi.org/10.1080/10826070701360368.
- H. Salem, S.M Riad, M.R. Rezk and K. Ahmed, J. Chromatogr. Sep. Techniq., 5, 221 (2014); https://doi.org/10.4172/2157-7064.1000221.
- S.M. Gosavi and M.A. Tayade, J. Chromatogr. Sep. Techniq., 8, 360 (2017); https://doi.org/10.4172/2157-7064.1000360.
- L. Sivasubramanian and V. Anilkumar, Indian J. Pharm. Sci., 69, 674 (2007); https://doi.org/10.4103/0250-474X.38474.
- W.-K. Kang, D.-S. Kim, K.-I. Kwon, Arch. Pharm. Res., 22, 86 (1999); https://doi.org/10.1007/BF02976443.
- M. Altun, D. Karakas and G. Bilsel, J. Chem. Metrol., 10, 27 (2016);
- L. Zanitti, R. Ferretti, B. Gallinella, F. La Torre, M.L. Sanna, A. Mosca and R. Cirilli, J. Pharm. Biomed. Anal., 52, 665 (2010); https://doi.org/10.1016/j.jpba.2010.02.021.
- M. Ribani, C.H. Collins and C.B.G. Bottoli, J. Chromatogr. A, 1156, 201 (2007); https://doi.org/10.1016/j.chroma.2006.12.080.
- W. Zhao, S. Leroux, V. Biran and E. Jacqz-Aigrain, Br. J. Clin. Pharmacol., 84, 997 (2018); https://doi.org/10.1111/bcp.13526.
- S. Gopalakrishnan, K. Jothy and K. Dhanalakshmi, Elixir Appl. Chem., 52, 11283 (2012).
- Vijayaraghavan, G. Jayababu, R. Prasad, P.E. Thirugnanam, V.T. Sriraam, G. Shivkumar, V.T. Sriraam and G. Ramesh Kumar, Int. J. Pharm. Sci. Res., 2, 2475 (2011); https://doi.org/10.13040/IJPSR.0975-8232.2(9).2475-81.
- R.T. Addo, K. Davis, R. Ubale, J.S. Owen and E.B. Watkins, AAPS PharmSciTech., 16, 30 (2015); https://doi.org/10.1208/s12249-014-0207-7.
- The United States Pharmacopoeia 39 and National Formulary 34, United States Pharmacopoeia, Rockville Convection (2016).
- International Conference on Harmonization, Q2 (R1), Validation of Analytical Procedures: Text and Methodology, ICH Guidelines (2005).
- International Conference on Harmonization, Q1B, Photo-stability Testing of New Drug Substances and Products, ICH Guidelines (1996).
- P.M. Hald, J. Biol. Chem., 167, 499 (1947).
- B. Sen, Fresenius' Z. Anal. Chem., 157, 2 (1957); https://doi.org/10.1007/BF00458072.
- R.B. Muter and C.F. Cockrell, Appl. Spectrosc., 23, 493 (1969); https://doi.org/10.1366/000370269774380572.
- V.A. Murphy, Anal. Biochem., 161, 144 (1987); https://doi.org/10.1016/0003-2697(87)90664-6.
- C.V.S. Ieggli, D. Bohrer, P.C. do Nascimento, L.M. de Carvalho and S.C. Garcia, Talanta, 80, 1282 (2010); https://doi.org/10.1016/j.talanta.2009.09.024.
- A. Krejcová, T. Cernohorský and E. Curdová, J. Anal. At. Spectrom., 16, 1002 (2001); https://doi.org/10.1039/B101941O.
References
Q1A (R2) Stability Testing of New Drug Substances and Products.
S. Goswami and P.K. Das, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 863, 9 (2008); https://doi.org/10.1016/j.jchromb.2007.12.016.
Crystallineformofomeprazolesodiumsalt, https://patents.google.com/patent/DE69811892T2/en. https://patents.google.com/patent/WO2004037253A1/en.
A.P. Micheel, C.Y. Ko and H.Y. Guh, J. Chromatogr. B Biomed. Sci. Appl., 709, 166 (1998); https://doi.org/10.1016/S0378-4347(98)00048-6.
L. Gonzalez, J.A. Lopez, R.M. Alonso and R.M. Jimenez, J. Chromatogr. A, 949, 49 (2002); https://doi.org/10.1016/S0021-9673(01)01496-0.
N. Ferreiros, G. Iriarte, R. Alonso and R. Jimenez, Talanta, 73, 748 (2007); https://doi.org/10.1016/j.talanta.2007.04.062.
Indian Pharmacopoeia, Govt. of India, Ministry of Health and Family Welfare, Published by The Controller of Publications: New Delhi, vol. II (1996).
J. Pentchuk, P. Alumaa, J. Ivask and M. Käärik, Proc. Estonian Acad. Sci. Chem., 54, 189 (2005).
H. Small, Ion Chromatography, Plenum Press, New York (1989).
J. Weiss, Ion Chromatography, VCH, Weinheim, edn 2 (1995).
S. Schnell, S. Ratering and K. Jansen, Environ. Sci. Technol., 32, 1530 (1998); https://doi.org/10.1021/es970861g.
USEPA Method, 300.7, Dissolved Sodium, Ammonium, Potassium, Magnesium and Calcium in Wet Depositionby Chemically Suppressed Ion Chromatography, USEPA, Cincinnati, OH, USA (1986).
Australian Standard AS 3741-1990, Recommended Practice for Chemical Analysis by Ion Chromatography, Standards Australia, North Sydney, NSW (1990).
K.A. Welch, W.B. Lyons, E. Graham, K. Neumann, J.M. Thomas and D. Mikesell, J. Chromatogr. A, 739, 257 (1996); https://doi.org/10.1016/0021-9673(96)00044-1.
J. Ivask and J. Pentchuk, J. Chromatogr. A, 770, 125 (1997); https://doi.org/10.1016/S0021-9673(96)01084-9.
N. Gros and B. Gorenc, J. Chromatogr. A, 789, 323 (1997); https://doi.org/10.1016/S0021-9673(97)00781-4.
N. Gros and B. Gorenc, J. Chromatogr. A, 770, 119 (1997); https://doi.org/10.1016/S0021-9673(97)00060-5.
D.A. Shah, A. Patel, S.L. Baldania, U.K. Chhalotiya and K.K. Bhatt, ISRN Spectrosc., Article ID 459820 (2013); https://doi.org/10.1155/2013/459820.
S.S. Perumal, S.P. Ekambaram and S. Raja, J. Food Drug Anal., 22, 520 (2014); https://doi.org/10.1016/j.jfda.2014.05.003.
K. Lakshmidurga, T.R.M. Reddy, A. Ajitha and V.U.M. Rao, J. Pharm. Chem., 8, 14 (2014).
T.J. Chaudhary and S. Bhadani, Am. J. PharmTech Res., 3, 2249 (2013).
G.A. Phadtare, S.C. Daswadkar and M.A. Kuchekar, Int. J. Appl. Pharm. Arch., 1, 92 (2016).
S. Pandey, P. Pandey, D. Mishra and U.K. Singh, Braz. J. Pharm. Sci., 49, 175 (2013); https://doi.org/10.1590/S1984-82502013000100019.
A. Kumar, M. Debnath, B. Vinod and J.V.L.N. Seshagiri Rao, Int. J. Pharmacol. Pharm. Sci., 3, 19 (2016).
F Ali, G.N. Singh, P.L. Sahu, A. Prakash, M. Trivedi and T.A. Khan, World J. Pharm. Pharm. Sci., 4, 1145 (2015).
S. Ashour and S. Omar, Arab. J. Chem., 9, S114 (2016); https://doi.org/10.1016/j.arabjc.2011.02.010.
D. Bageshwar, V. Khanvilkar and V. Kadam, J. Pharm. Anal., 1, 275 (2011); https://doi.org/10.1016/j.jpha.2011.09.012.
K.E. McCarthy, Q. Wang, E.W. Tsai, R.E. Gilbert, D.P. Ip and M.A. Brooks, J. Pharm. Biomed. Anal., 17, 671 (1998); https://doi.org/10.1016/S0731-7085(97)00251-3.
S.U. Rakesh, P.R. Patil, P.N. Dhabale and K.B. Burade, J. Pharmacy Res., 2, 1252 (2009).
M.S. Kishore and K.K. Kumar, Der Pharm. Chem., 6, 171 (2014).
M. Stolarczyk, A. Maslanka, A. Apola and J. Krzek, Acta Pol. Pharm., 70, 967 (2013).
H.M. Hafez, A.A. Elshanawane, L.M. Abdelaziz and M.M. Kamal, Iran. J. Pharm. Res., 12, 635 (2013).
M.S. Kishore, K.K. Kumar, G. Ramu and C. Rambabu, Der Pharm. Lett., 7, 75 (2015).
A. Farnoudian-Habibi, S. Kangari, B. Massoumi and M. Jaymand, RSC Adv., 5, 102895 (2015); https://doi.org/10.1039/C5RA20117A.
S.V.S.G.B. Prasad, S. Shivakumar, T. Sudhir, R. Mital and G.D. Rao, Int. J. Pharm. Pharm. Sci., 1 (Suppl. 1), 206 (2009).
B. Patel, M. Patel, J. Patel and B. Suhagiam, J. Liq. Chromatogr. Rel. Technol., 30, 1762 (2006); https://doi.org/10.1080/10826070701360368.
H. Salem, S.M Riad, M.R. Rezk and K. Ahmed, J. Chromatogr. Sep. Techniq., 5, 221 (2014); https://doi.org/10.4172/2157-7064.1000221.
S.M. Gosavi and M.A. Tayade, J. Chromatogr. Sep. Techniq., 8, 360 (2017); https://doi.org/10.4172/2157-7064.1000360.
L. Sivasubramanian and V. Anilkumar, Indian J. Pharm. Sci., 69, 674 (2007); https://doi.org/10.4103/0250-474X.38474.
W.-K. Kang, D.-S. Kim, K.-I. Kwon, Arch. Pharm. Res., 22, 86 (1999); https://doi.org/10.1007/BF02976443.
M. Altun, D. Karakas and G. Bilsel, J. Chem. Metrol., 10, 27 (2016);
L. Zanitti, R. Ferretti, B. Gallinella, F. La Torre, M.L. Sanna, A. Mosca and R. Cirilli, J. Pharm. Biomed. Anal., 52, 665 (2010); https://doi.org/10.1016/j.jpba.2010.02.021.
M. Ribani, C.H. Collins and C.B.G. Bottoli, J. Chromatogr. A, 1156, 201 (2007); https://doi.org/10.1016/j.chroma.2006.12.080.
W. Zhao, S. Leroux, V. Biran and E. Jacqz-Aigrain, Br. J. Clin. Pharmacol., 84, 997 (2018); https://doi.org/10.1111/bcp.13526.
S. Gopalakrishnan, K. Jothy and K. Dhanalakshmi, Elixir Appl. Chem., 52, 11283 (2012).
Vijayaraghavan, G. Jayababu, R. Prasad, P.E. Thirugnanam, V.T. Sriraam, G. Shivkumar, V.T. Sriraam and G. Ramesh Kumar, Int. J. Pharm. Sci. Res., 2, 2475 (2011); https://doi.org/10.13040/IJPSR.0975-8232.2(9).2475-81.
R.T. Addo, K. Davis, R. Ubale, J.S. Owen and E.B. Watkins, AAPS PharmSciTech., 16, 30 (2015); https://doi.org/10.1208/s12249-014-0207-7.
The United States Pharmacopoeia 39 and National Formulary 34, United States Pharmacopoeia, Rockville Convection (2016).
International Conference on Harmonization, Q2 (R1), Validation of Analytical Procedures: Text and Methodology, ICH Guidelines (2005).
International Conference on Harmonization, Q1B, Photo-stability Testing of New Drug Substances and Products, ICH Guidelines (1996).
P.M. Hald, J. Biol. Chem., 167, 499 (1947).
B. Sen, Fresenius' Z. Anal. Chem., 157, 2 (1957); https://doi.org/10.1007/BF00458072.
R.B. Muter and C.F. Cockrell, Appl. Spectrosc., 23, 493 (1969); https://doi.org/10.1366/000370269774380572.
V.A. Murphy, Anal. Biochem., 161, 144 (1987); https://doi.org/10.1016/0003-2697(87)90664-6.
C.V.S. Ieggli, D. Bohrer, P.C. do Nascimento, L.M. de Carvalho and S.C. Garcia, Talanta, 80, 1282 (2010); https://doi.org/10.1016/j.talanta.2009.09.024.
A. Krejcová, T. Cernohorský and E. Curdová, J. Anal. At. Spectrom., 16, 1002 (2001); https://doi.org/10.1039/B101941O.