Scopus (CiteScore 2022 =3.0, Q3) , ISC

Document Type : Original Research Article

Authors

Department of Analytical Chemistry, Faculty of Pharmacy, Ataturk University, 25240, Erzurum, Turkey

Abstract

This research study discusses two rapid, sensitive and specific methods for simultaneous determination of rosuvastatin (ROS) and amlodipine (AML) in pharmaceutical preparations using the differential pulse voltammetry (DPV) and high-performance liquid chromatography (HPLC). Electrochemical behavior and simultaneous voltammetric determination of ROS and AML were investigated using the platinum disk electrode. HPLC was also developed for the comparison. The flow rate of the mobile phase was 1.0 mL/min and all the detections were carried out at 225 nm using the UV detection. The calibration curve was established over the concentration range of 0.5-4 mg/mLfor DPV and 0.1-2 mg/mLfor HPLC. The intra- and inter-day relative standard deviation was less than 2.96 and 3.07% for DPV and HPLC, respectively. Limits of quantification were determined as 0.21 and 0.06 mg/mLfor DPV and HPLC, respectively. Both the drugs along with their degradation products were separated in less than 8 min. No interference was found from tablet excipients at the selected assay conditions. The methods were applied for the quality control of the commercial ROS and AML drug.

Graphical Abstract

Simultaneous determination of rosuvastatin and amlodipine in binary mixtures by differential pulse voltammetry and HPLC methods

Keywords

Main Subjects

[1] J. Shepherd, Am. J. Cardiol., 1998, 82, 57T-59T
[2] D. Williams, J. Feely, Clin. Pharmacokinet., 2002, 41, 343-370
[3] J.W. Jukema, A.H. Zeinderman, A.J. Van Boven, J.H. Reiber, A. Van Der Laarse, K.I. Lie,  A.V. Bruschke,  Arterioscler Thromb. Vasc. Biol., 1996, 16, 425-430
[4] A.G. Olsson, F. McTaggart, A. Raza, Cardiovasc. Drug Rev., 2002, 20, 303-328.
[5] J.W. Blasetto, E.A. Stein, W.V. Brown, R. Chitra, A. Raza, Am. J. Cardiol., 2003, 91, 3C-10C
[6] P.D. Martin, A.L. Dane, O.M. Nwose, D.W. Schneck, M.J. Warwick, J.Clin. Pharmacol., 2002, 42, 1116-1121
[7] P.D. Martin, P.D. Mitchell, D.W. Schneck, Br. J. Clin. Pharmacol., 2002, 54, 472-477
[8] P.D. Martin, M.J. Warwick, A.L. Dane, C. Brindley, T. Short, Clin. Ther., 2003, 25, 2553-2563
[9] J.W. Jukema,  J.W. Van Der Hoorn, Expert Opin. Pharmacother., 2004, 5, 459-468
[10] B.Y. Kang, W. Wang, P. Palade, S.G. Sharma, J.L. Mehta, J. Cardiovas. Pharmacol., 2009, 54, 327-334
[11] N. Karadas Bakirhan, M. Gumustas, B. Uslu, S.A. Ozkan, Ionics 2016, 22, 277-288
[12] D. Tajane, A.M. Raurale, P.D. Bharande, A.N. Mali, A.V. Gadkari, V.R. Bhosale, J. Chem. Pharm. Res., 2012, 4, 2789-2794
[13] S.K. Banerjee, N.M. Vasava, Bull. Pharm. Res., 2013, 3, 29-33
[14] G.B. El-Hefnawey,  I.S. El-Hallag,  E.M. Ghoneim, M.M. Ghoneim, J. Pharm. Biomed. Anal., 2004, 34, 75-86
[15] P. Corti, G. Corbini, P. Gratteri, S. Furlanetto, S. Pinzauti,  Int. J. Pharm., 1994, 11, 83-87
[16] A. Radi, T. Elmogy, IL Farmaco, 2005, 60, 43-46
[17] United States Pharmacopeia 32 (USP 32) Revision; United States Pharmacopeia Convention, Rockville, MD, USA, 2009
[18] I.C.H, Stability testing of new drug substances and products, Q1A(R2). International Conference on Harmonization; IFPMA, Geneva, 2003
[19] E. Laviron, L. Roullier, C. Degrand, J. Electroanal. Chem., 1980, 112, 11-23
[20] B. Yilmaz, D. Ekinci, Rev. Anal. Chem., 2011, 30, 187-193
[21] E. Arkan, Z. Karimi, M. Shamsipur, R. Saber, J. Reports Pharmaceutical Sci., 2014, 3, 99-107
[22] Z.Z. Stoiljkovic, M.L. Avramov Ivic, S.D. Petrovic, D.Z. Mijin, S.I. Stevanovic, U.C. Lacnjevac, A.D. Marinkovic, Int. J. Electrochem. Sci., 2012, 7, 2288-2303
[23] A.A. Ramadan, H. Mandil, N. Ghazal, Int. J. Pharmacy Pharmaceutical Sci., 2014, 6, 128-133
[24] S. Altınoz, B. Uyar,  Anal. Methods, 2013, 5, 5709-5716
[25] T.A. Silva, H. Zanin, F.C. Vicentini, E.J. Corat, O. Fatibello-Filho, Sensors Act. B Chemical, 2015, 218, 51-59
[26] M. Ashfaq, T. Akhtar, G. Mustafa, M. Danish, S.N. Razzaq, M.F. Nazar, Braz. J. Pharm. Sci., 2014, 50, 629-638
[27] US DHHS. FDA and CDER. Guidance for industry: bioanalytical method validation. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research and Center for Veterinary Medicine, 2001
 [28] Guideline on bioanalytical method validation. Science and Medicinal Health. European Medicines Agency (EMEA). EMEA/CHMP/EWP/192217/2009, 2011
[29] ICH, Topic Q2A validation of analytical procedures, methodology, PMP/ICH/281/95.
[30] C.M Riley , T.W. Rosanske, Development and validation of analytical methods. Elsevier; New York, 1996
[31] M.E. Swartz, I.S. Krull, Analytical method development and validation. Marcel Dekker, New York, 1997
[32] The United States Pharmacopoeia. 24th revision, Easton, Rand Mc Nally Taunton, 2000.