A Quick and Sensitive Liquid Chromatography-Tandem Mass Spectrometry (LC-MS) Method for the Evaluation of Two Formulations of Amlodipine and Atorvastatin in Healthy Male Volunteers

Document Type : Research Article

Authors

1 Department of Pharmaceutics, School of Pharmacy, Zanjan University of Medical Sciences, Postal code 45139-56184, Zanjan, Iran

2 Department of Pharmaceutics, School of Pharmacy, Zanjan University of Medical Sciences, Zanjan, I.R. IRAN

Abstract

An open-label, single-dose, randomized, 2-way crossover study was conducted in fasted healthy Iranian male volunteers. Eligible participants randomly assigned in a 1:1 ratio to be given one tablet of the test or reference formulation, followed by a 2-week washout period and administration of the exchange formulation. A quick and susceptible Liquid Chromatography–tandem Mass Spectrometry (LC-MS) method for the evaluation of amlodipine and atorvastatin in tablets.Revealing of analysts was achieved by tandem mass spectrometry with ElectroSpray Ionization (ESI) interface in positive ion mode was operated under the multiple-reaction monitoring mode. The assay results ascertain the presence and compendia quality of amlodipine and atorvastatin in all these products. The validation tests on the developed method indicated an acceptable degree of linearity, sensitivity, precision, accuracy and recovery for the method. The intra-day and inter-day precision and accuracy results were well within the acceptable limits. The method is rapid, simple, very stable and specific for the partition, assignment, evaluation of amlodipine and atorvastatin healthy Iranian adult male volunteers.

Keywords

Main Subjects

References

[1] Bahl V., Jadhav U., Thacker H. Reduction in Cardiovascular Events in Hypertensive, Am. J. Cardiovasc. Drugs, 9:135–142(2009).
[2] Grimm R., Malik M., Yunis C., Sutradhar S., Kursun A., Vasc. Simultaneous Treatment to Attain Blood Pressure and Lipid Goals and Reduced CV Risk Burden Using Amlodipine/Atorvastatin Single-Pill Therapy in Treated Hypertensive Participants in a Randomized Controlled Trial, Health Risk Manage, 6: 261-271 (2010)
[3] http://www.pfizer.com/files/products/uspi caduet.pdf
[4] Sweetman S.C., Martindale D., “The Complete Drug Reference”, 34th ed., Pharmaceutical Press, London, pp. 862-866 (2005).
[5] Dollery C., Therapeutic Drugs, 2nd ed., Churchill Livingstone UK 151-160 (1999).
[6] Mckeage K., Siddiqui M.A., Amlodipine/Atorvastatin Fixed-Dose Combination: a Review of Its Use in the Prevention of Cardiovascular Disease and in the Treatment of Hypertension and Dyslipidemia, Am. J. Cardiovasc Drugs 8: 51–67 (2008).
[7] Jacobsen W., Kuhn B., Soldner A., Kirchner G., Sewing K.F., Kollman P.A., Benet L.Z., Chritians U., It is Important in the Metabolism of Many Drugs Including Paclitaxel, Rosiglitazone, Mass Spectrometer SCIEX API, Drug Metab. Dispos., 28: 1369–1378 (2000).
[8] Molden E., Skovlund E., Braathen P., Risk Management of Simvastatin or Atorvastatin Interactions with CYP3A4 Inhibitors, Drug Saf., 31: 587–596 (2008).
[9] Zou Q., Zhan Y., Ge Z., Wei P., Ouyang P., Sensitive HPLC Method with Fluorescence Detection and on-Line Wavelength Switching for Simultaneous Determination of Valsartan and Amlodipine in Human Plasma, Arzneimittel for Schung, 59: 383–391 (2009).
[10] Ramani A.V., Sengupta P., Mullangi R., Development and Validation of a Highly Sensitive and Robust LC-ESI-MS/MS Method for Simultaneous Quantitation of Simvastatin Acid, Amlodipine and Valsartan in Human Plasma: Application to a Clinical Pharmacokinetic Study, Biomed. Chromatogr, 23: 615–622 (2009).
[11] Bhatt J., Singh S., Subbaiah G., Shah B., Kamali S., Ameta S., A Rapid and Sensitive Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Method for the Estimation of Amlodipine in Human, Biomed. Chromatogr, 21: 169–175 (2007).
[12] Novakkova L., Vlckova H., Satinsky D., Sadilek P., Solichova D.,  Blaha  M., Solich P., Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application, J. Chromatogr. B 877: 2093–2103(2009).
[13] Ying Z., Jie L., Xia H., Mengmong J., 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 to a Bioequivalence Study, Journal of Pharmaceutical and Biomedical Analysis, 83:101–107 (2013).
[14] Pilli N.R., Inamaduga J.K., Mulligana R., Karra V.K., Vaidya J.R., Seshagiri R.A.O., Simultaneous Determination of Atorvastatin, Amlodipine, Ramipril and Benazepril in Human Plasma by LC-MS/MS and Its Application to a Human Pharmacokinetic Study, Biomed. Chromatogr., 25: 439-449 (2011).
[15] Mohammad Y., Ahmad A., Mahmud A., Simultaneous Extermination of Amlodipine and Atorvastatin with its Metabolites; Ortho and Para Hydroxy Atorvastatin; in Human Plasma by LC–MS/MS, J Chromatogr., B917: 36-47 (2013).
[16] Zhe HU., Fan-Yuan Z., Jin Z., HPLC–MS–MS for the Simultaneous Determination of Atorvastatin and Amlodipine in Plasma of Hypertensive Patients, Chromatographia, 73: 257–262 (2011).
[17] MohammadiA.,Rezanour N., Ansari M., A Stability-Indicating High-Performance Liquid Chromatographic (HPLC) Assay for the Simultaneous Determination of Atorvastatin and Amlodipine in Commercial Tablets, J. Chromatogr. B 846: 215–221(2007).
[18] Asadi S., Gharbani P., Simultaneous Determination of Sulfamethoxazole and Phthalazine by HPLC and Multivariate Calibration Methods, Iran. J. Chem. Chem. Eng. (IJCCE), 32(2): 1-15 (2013).
[19] Danafar H., Hamidi M., A Rapid and Sensitive LC–MS Method for Determination of Ezetimibe Concentration in Human Plasma, Application to a Bioequivalence Study, Chromatographia, 76: 1667-1675 (2013).
[20] Danafar H., Hamidi M., Simple and Sensitive High-Performance Liquid Chromatography (HPLC) Method with UV Detection for Mycophenolic Acid Assay in Human Plasma. Application to a Bioequivalence Study, Adv. Pharm. Bull., 5: 563-568(2015)
[21] Danafar H., Hamidi, M., A Quick and Sensitive Liquid Chromatography–Tandem Mass Spectrometry (LC-MS) Method for the Determination of Enalapril and Enalaprilat in Human Plasma: Application to a Bioequivalence Study, Iranian Journal of Pharmaceutical Sciences., 10(3): 21-34. (2014).
[22] Danafar H., Hamidi M., LC-MS Method for Studying the Pharmacokinetics and Bioequivalence of Clonidine Hydrochloride in Healthy Male Volunteers, Avicenna J. Med. Biotech., 8(2): 91-98 (2016). 

Files

Share

How to cite

Statistics