Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets

1. A. C. Moffat, M. D. Osselton and B. Widdop, Clarke’s Analysis of Drugs and Poisons, Pharmaceutical Press, London 2011.Search in Google Scholar

2. L. L. Brunton, J. S. Lazo and K. L. Parker (Eds.), Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 11th ed., McGraw-Hill, New York 2006.10.1345/aph.1G685Search in Google Scholar

3. British Pharmacopoeia, Medicines and Healthcare Products Regulatory Agency (MHRA), London 2013.Search in Google Scholar

4. United States Pharmacopeia, United States Pharmacopeial Convention, Rockville 2011.Search in Google Scholar

5. H. W. Darwish, S. A. Hassan, M. Y. Salem and B. A. El-Zeany, Sequential spectrophotometric method for the simultaneous determination of amlodipine, valsartan, and hydrochlorothiazide in coformulated tablets, Int. J. Spectrosc. 2013 (2013) article ID 273102; DOI: 10.1155/2013/273102.10.1155/2013/273102Search in Google Scholar

6. D. Ramesh and M. Habibuddin, Stability indicating RP-HPLC method for the simultaneous determination of atorvastatin calcium, metformin hydrochloride, and glimepiride in bulk and combined tablet dosage form, Int. Schol. Res. Not. 2014 (2014) article ID 754695; DOI: 10.1155/2014/754695.10.1155/2014/754695489731527433531Search in Google Scholar

7. H. W. Darwish, S. A. Hassan, M. Y. Salem and B. A. El-Zeany, Different approaches in partial least squares and artificial neural network models applied for the analysis of a ternary mixture of amlodipine, valsartan and hydrochlorothiazide, Spectrochim. Acta A 122 (2014) 744-750; DOI: 10.1016/j.saa.2013.11.045.10.1016/j.saa.2013.11.04524378624Search in Google Scholar

8. B. Ramesha, K. V. Reddy, B. Kishore, M. A. Kumar, L. Raju and B. Thara, Development and validation of a stability-indicating gradient RP-UHPLC method for the determination of impurities in atorvastatin drug substance, J. Liq. Chromatogr. Relat. Technol. 37 (2014) 275-297; DOI: 10.1080/10826076.2012.745135.10.1080/10826076.2012.745135Search in Google Scholar

9. A. A. Elshanawane, L. M. Abdelaziz, M. M. Kamal and H. M. Hafez, Quantitative determination of telmisartan, ramipril, amlodipine besylate, and atorvastatin calcium by HPLC, J. Liq. Chromatogr. Relat. Technol. 37 (2014) 195-206; DOI: 10.1080/10826076.2012.738622.10.1080/10826076.2012.738622Search in Google Scholar

10. E. S. Elzanfaly, S. A. Hassan, M. Y. Salem and B. A. El-Zeany, Continuous wavelet transform, a powerful alternative to derivative spectrophotometry in analysis of binary and ternary mixtures: A comparative study, Spectrochim. Acta A 151 (2015) 945-955; DOI: 10.1016/j.saa.2015.06.100.10.1016/j.saa.2015.06.10026186613Search in Google Scholar

11. M. M. Bkhaitan and A. Z. Mirza, Stability‐indicating HPLC‐DAD method for simultaneous determination of atorvastatin, irbesartan, and amlodipine in bulk and pharmaceutical preparations, Bull. Korean Chem. Soc. 36 (2015) 2230-2237; DOI: 10.1002/bkcs.10433.10.1002/bkcs.10433Search in Google Scholar

12. S. A. Hassan, E. S. Elzanfaly, M. Y. Salem and B. A. El-Zeany, Mean centering of double divisor ratio spectra, a novel spectrophotometric method for analysis of ternary mixtures, Spectrochim. Acta A 153 (2016) 132-142; DOI: 10.1016/j.saa.2015.07.109.10.1016/j.saa.2015.07.10926298680Search in Google Scholar

13. H. W. Darwish, S. A. Hassan, M. Y. Salem and B. A. El-Zeiny, Three different spectrophotometric methods manipulating ratio spectra for determination of binary mixture of amlodipine and atorvastatin, Spectrochim. Acta A 83 (2011) 140-148; DOI: 10.1016/j.saa.2011.08.005.10.1016/j.saa.2011.08.00521908232Search in Google Scholar

14. Y. Zhou, J. Li, X. He, M. Jia, M. Liu, H. Li, Z. Xiong, Y. Fan and W. Li, Development and validation of a liquid chromatography-tandem mass spectrometry method for simultaneous determination of amlodipine, atorvastatin and its metabolites ortho-hydroxy atorvastatin and para-hydroxy atorvastatin in human plasma and its application in a bioequivalence study, J. Pharm. Biomed. Anal. 83 (2013) 101-107; DOI: 10.1016/j.jpba.2013.04.021.10.1016/j.jpba.2013.04.02123711572Search in Google Scholar

15. H. W. Darwish, S. A. Hassan, M. Y. Salem and B. A. El-Zeany, Development and validation of Hpoint standard addition method applied for the analysis of binary mixture of amlodipine and atorvastatin, Int. J. Pharm. Bio Sci. 4 (2013) 230-243.Search in Google Scholar

16. A. Mohammadi, A. B. Moghaddam, K. Eilkhanizadeh, E. Alikhani, S. Mozaffari and T. Yavari, Electro-oxidation and simultaneous determination of amlodipine and atorvastatin in commercial tablets using carbon nanotube modified electrode, Micro Nano Lett. 8 (2013) 413-417; DOI: 10.1049/ mnl.2013.0080.10.1049/mnl.2013.0080Search in Google Scholar

17. B. A. Moussa, A. A. El-Zaher, M. A. Mahrouse and M. S. Ahmed, Simultaneous determination of amlodipine besylate and atorvastatin calcium in binary mixture by spectrofluorimetry and HPLC coupled with fluorescence detection, Anal. Chem. Insights 8 (2013) 107-115; DOI: 10.4137/ACI.S12921.10.4137/ACI.S12921382565024250220Search in Google Scholar

18. H. W. Darwish, S. A. Hassan, M. Y. Salem and B. A. El-Zeany, Three different methods for determination of binary mixture of amlodipine and atorvastatin using dual wavelength spectrophotometry, Spectrochim. Acta A 104 (2013) 70-76; DOI: 10.1016/j.saa.2012.11.079.10.1016/j.saa.2012.11.07923266678Search in Google Scholar

19. P. Haritha, B. S. Rao and Y. Sunandamma, Method development and validation for simultaneous determination of amlodipine besylate and atorvastatin calcium by RP-HPLC technique, Asian J. Res. Chem. 7 (2014) 438-445.Search in Google Scholar

20. N . Ibrahim, M. Rizk, A. Ibrahim, S. Tawakkol and I. Ali, Simultaneous determination of amlodipine besylate and atorvastatin calcium by using spectrophotometric method with multivariate calibration and HPLC method implementing „design of experiment”, Int. J. Pharm. Pharm. Sci. 6 (2014) 419-425.Search in Google Scholar

21. A. L. Vonica-Gligor, T. Casian, A. Reznek, I. Tomuta and F. Gligor, Simultaneous quantification of atorvastatin and amlodipine in powder blends for tableting by NIR spectroscopy and chemometry, Farmacia 63 (2015) 381-387.Search in Google Scholar

22. B. G. Chaudhari, N. M. Patel and P. B. Shah, Stability indicating RP-HPLC method for simultaneous determination of atorvastatin and amlodipine from their combination drug products, Chem. Pharm. Bull. (Tokyo) 55 (2007) 241-246; DOI: 10.1248/cpb.55.241.10.1248/cpb.55.24117268096Search in Google Scholar

23. A. Mohammadi, N. Rezanour, M. Ansari Dogaheh, F. Ghorbani Bidkorbeh, M. Hashem and R. Walker, A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets, J. Chromatogr. B 846 (2007) 215-221; DOI: 10.1016/j.jchromb.2006.09.007.10.1016/j.jchromb.2006.09.00717010681Search in Google Scholar

24. D. Shah, K. Bhatt, R. Mehta, S. Baldania and T. Gandhi, Stability indicating RP-HPLC estimation of atorvastatin calcium and amlodipine besylate in pharmaceutical formulations, Indian J. Pharm. Sci. 70 (2008) 754-760; DOI: 10.4103/0250-474X.49117.10.4103/0250-474X.49117304086921369436Search in Google Scholar

25. M. Hefnawy, M. Sultan and H. Al-Johar, Development of capillary electrophoresis technique for simultaneous measurement of amlodipine and atorvastatin from their combination drug formulations, J. Liq. Chromatogr. Relat. Technol. 32 (2009) 2923-2942; DOI: 10.1080/10826070903320681.10.1080/10826070903320681Search in Google Scholar

26. H. W. Darwish, S. A. Hassan, M. Y. Salem and B. A. El-Zeany, Advanced stability indicating chemometric methods for quantitation of amlodipine and atorvastatin in their quinary mixture with acidic degradation products, Spectrochim. Acta A 154 (2016) 58-66; DOI: 10.1016/j.saa.2015.10.007.10.1016/j.saa.2015.10.00726513228Search in Google Scholar

27. A. A. Shirkhedkar and S. J. Surana, Simultaneous densitometric TLC analysis of atorvastatin calcium and fenofibrate in the bulk drug and in pharmaceutical formulations, J. Planar Chromatogr.- Mod. TLC 22 (2009) 355-358; DOI: 10.1556/JPC.22.2009.5.7.10.1556/JPC.22.2009.5.7Search in Google Scholar

28. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH, Nov 2005. Search in Google Scholar