Abstract
In the proposed work, the simultaneous analysis of amlodipine–rosuvastatin and amlodipine–atorvastatin in their dosage forms was achieved. Simultaneous dissolution profiles of the amlodipine–rosuvastatin and amlodipine–atorvastatin tablets are realized using Apparatus II with a simple, accurate and precise RP-LC method. The mobile phase consisting of 0.2 % H3PO4 and pH 5:methanol:acetonitrile (46:27:27) was used. The samples of 10 µL were injected onto a Zorbax SB C18 (100 mm, 4.6 mm, 3.5 µm particle size) column with 1.2 µL min−1 flow rate. The samples were detected at 236 nm. By plotting peak area ratios vs. concentration, the linearity for amlodipine–rosuvastatin and amlodipine–atorvastatin was determined. With the developed RP-LC method, AML, ROS and ATOR were detected within the range of 0.25–10, 0.5–10 and 0.25–25 µg mL−1, respectively. LOD and LOQ values were also calculated as 0.028, 0.058, 0.021 and 0.095 µg mL−1, 0.195 µg mL−1, 0.070 µg mL−1 for AML, ROS and ATOR, respectively. System suitability tests parameters, such as capacity factor, selectivity to previous peak, selectivity to next peak, resolution to previous peak, resolution to next peak, tailing factor, theoretical number of plates, were performed and found coherent with the ICH guideline parameters. The proposed method has been extensively validated in terms of recovery, and recovery results were between 99 and 101 %. For proving the precision, between-day and within-day repeatability results of the method were proposed. The method can be used for the simultaneous determination of amlodipine–rosuvastatin and amlodipine–atorvastatin.
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References
Karthikeyan VJ (2005) Adverse effects of statins: an update. Adverse Drug React Bull 233:895–898
Kaldara E, Sanoudou D, Adamopoulos S, Nanas JN (2015) Outpatient management of chronic heart failure. Expert Opin Pharmacother 16:17–41
Endo A (1992) The discovery and development of HMG-CoA reductase inhibitors. J Lipid Res 33:1569–1582
Schultheis A (1990) Hypercholesterolemia: prevention, detection and management. Nurse Pract 15:51–56
Stein EA (1989) Management of hypercholesterolemia: approach to diet and drug therapy. Am J Med 87:S20–S27
Meredith PA, Elliott HL (1992) Clinical pharmacokinetics of amlodipine. Clin Pharmacokinet 22:22–31
Kang D, Verotta D, Schwartz JB (2006) Population analyses of amlodipine in patients living in the community and patients living in nursing homes. Clin Pharmacol Ther 79:114–124
Murdoch D, Heel RC (1991) Amlodipine: a review of its pharmacodynamics and pharmacokinetic properties, and therapeutic use in cardiovascular disease. Drugs 41:478–505
Haria M, Wagstaff AJ (1995) Amlodipine: a reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease. Drugs 50:560–586
Faulkner JK, Hayden ML, Chasseaud LF, Taylor T (1989) Absorption of amlodipine unaffected by food: solid dose equivalent to solution dose. Arzneimittelforschung 39:799–801
Abernethy DR, Gutkowska J, Winterbottom LM (1990) Effects of amlodipine, a long acting dihydropyridine calcium antagonist in ageing hypertension: pharmacodynamics in relation to disposition. Clin Pharmacol Ther 48:76–86
Pfammatter JP, Clericetti-Affolter CC, Truttmann AC, Busch K, Laux-End R, Bianchetti MG (1998) Amlodipine once-daily in systemic hypertension. Eur J Pediatr 157:618–621
Flynn JT, Newburger JW, Daniels SR, Sanders SP, Portman RJ, Hogg RJ, Saul JP (2004) A randomized, placebo-controlled trial of amlodipine in children with hypertension. J Pediatr 145:353–359
Sweetman SC (ed) (2002) Martindale The complete drug reference, 32nd edn. Pharmaceutical Press, London, pp 1214–1215
Chong PH, Yim BT (2002) Rosuvastatin for the treatment of patients with hypercholesterolemia. Ann Pharmacother 36:93–101
White CM (2002) A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol 42:963–970
Kapur NK (2007) Rosuvastatin: a highly potent statin for the prevention and management of coronary artery disease. Expert Rev Cardiovasc Ther 5:161–175
McKenney JM (2005) Efficacy and safety of rosuvastatin in treatment of dyslipidemia. Am J Health-Syst Pharm 62:1033–1047
Olsson AG (2006) Expanding options with a wider range of rosuvastatin doses. Clin Ther 28:1747–1763
Crouse JR (2008) An evaluation of rosuvastatin: pharmacokinetics, clinical efficacy and tolerability. Expert Opin Drug Metab Toxicol 4:287–304
Sweetman SC (ed) (2002) Martindale. The complete drug reference, 32nd edn. Pharmaceutical Press, London, pp 1389–1390
Lennernäs H (2003) Clinical pharmacokinetics of atorvastatin. Clin Pharmacokinet 42:1141–1160
Black DM, Bakker-Arkema RG, Nawrocki JW (1998) An overview of the clinical safety profile of atorvastatin (Lipitor), a new HMG-CoA reductase inhibitor. Arch Intern Med 158:577–584
Bernini F, Poli A, Paoletti R (2001) Safety of HMG-CoA reductase inhibitors: focus on atorvastatin. Cardiovasc Drugs Ther 15:211–218
Malhotra HS, Goa KL (2001) Atorvastatin: an updated review of its pharmacological properties and use in dyslipidaemia. Drugs 61:1835–1881
Malinowski JM (1998) Atorvastatin: a hydroxymethylglutaryl-coenzyme A reductase inhibitor. Am J Health-Syst Pharm 55:2253–2267
Sweetman SC (ed) (2002) Martindale. The complete drug reference, 32nd edn. Pharmaceutical Press, London, pp 1218–1219
Löbenberg R, Amidon GL (2000) Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards. Eur J Pharm Biopharm 50:3–12
Jang DJ, Jeong EJ, Lee HM, Kim BC, Lim SJ, Kim CK (2006) Improvement of bioavailability and photostability of amlodipine using redispersible dry emulsion. Eur J Pharm Sci 28:405–411
Wu CY, Benet LZ (2005) Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res 22:11–23
FDA (1997) Guidance for industry: dissolution testing of immediate release solid oral dosage forms
Limberg J, Potthast H (2013) Regulatory status on the role of in vitro dissolution testing in quality control and biopharmaceutics in Europe. Biopharm Drug Dispos 34:247–253
The United States Pharmacopeia (The USP 32-NF 27) (2009) The official compendia of standards. United States Pharmacopeial Convention, Rockwille
Swartz ME, Krull IS (1997) Analytical method development and validation. Marcel Dekker, New York
Ermer J, Miller JH (2005) Method validation in pharmaceutical analysis, 1st edn. Wiley-VCH Pub, Germany
Riley CM, Rosanske TW (1996) Development and validation of analytical methods. Elsevier, Amsterdam
ICH Guidelines Topic (1995) Validation of analytical procedures, methodology international conference on harmonization, Brussels, Belgium
Gumustas M, Kurbanoglu S, Uslu B, Ozkan SA (2013) UPLC versus HPLC on drug analysis: advantageous, applications and their validation parameters. Chromatographia 76:1365–1427
ICH (2000) Stability testing of new drug substances and products (Q1AR) international conference on harmonization IFPMA, Geneva
Soni T, Chotai N (2010) Assessment of dissolution profile of marketed aceclofenac formulations. J Young Pharm 2:21–26
Patel N, Chotai N, Patel J, Soni T, Desai J, Patel R (2008) Comparison of in vitro dissolution profiles of oxcarbazepine-HP b-CD tablet formulations with marketed oxcarbazepine tablets. Dissol Technol 15:28–34
Jones P, Kafonek S, Laurora I, Hunninghake D (1998) Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study). Am J Cardiol 81:582–587
Jones PH, Davidson MH, Stein EA, Bays HE, McKenney JM, Miller E, Cain VA, Blasetto JW (2003) Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol 92:152–160
McTaggart F (2003) Comparative pharmacology of rosuvastatin. Atheroscler Suppl 4(1):9–14
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Ozkan, C.K., Kurbanoglu, S., Esim, O. et al. Simultaneous Determination and Drug Dissolution Testing of Combined Amlodipine Tablet Formulations Using RP-LC. Chromatographia 79, 1143–1151 (2016). https://doi.org/10.1007/s10337-016-3125-x
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DOI: https://doi.org/10.1007/s10337-016-3125-x