Abstract
Two methods were developed for separation and quantitation of amlodipine (AML) and atorvastatin (ATV) in the presence of their acidic degradation products. The first method was a simple isocratic RP-HPLC method while the second was capillary electrophoresis (CE). Degradation products were obtained by acidic hydrolysis of the two drugs and their structures were elucidated for the first time by IR and MS spectra. Degradation products did not interfere with the determination of either drug and the assays were therefore stability-indicating. The linearity of the proposed methods was established over the ranges 1-50 μg mL-1 for AML and ATV in the HPLC method and in the range of 3-50 and 4-50 μg mL-1 for AML and ATV, respectively, in the CE method. The proposed methods were validated according to ICH guidelines. The methods were successfully applied to estimation of AML and ATV in combined tablets.
References
1. A. C. Moffat, M. D. Osselton and B. Widdop, Clarke’s Analysis of Drugs and Poisons, Pharmaceutical Press, London 2011.
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.
3. British Pharmacopoeia, Medicines and Healthcare Products Regulatory Agency (MHRA), London 2013.
4. United States Pharmacopeia, United States Pharmacopeial Convention, Rockville 2011.
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.
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.
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.
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.
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. 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
