UPLCMS Method Development and Validation of Amlodipine, Hydrochlorthiazide and Losartan in Combined Tablet Dosage Form

DOI: 10.4236/ajac.2015.63021   PDF   HTML   XML   3,004 Downloads   3,839 Views   Citations

Abstract

A simple, rapid, sensitive and specific UPLCMS method was developed and validated following ICH guidelines for simultaneous estimation of tablet dosage form containing amlodipine (AMLO) hydrochlorothiazide (HCT) and losartan (LOSAT) using telmisartan (TELMI) as an internal standard (IS). The separation was achieved using Waters ACQUITY BEH C18 (1.7 μm, 2.1 × 50 mm) column with gradient mode, mobile phase containing acetonitrile (A) & 1% ammonium acetate (B) pH adjusted to 2.8 with trifluoro acetic acid with gradient mode. The flow rate was 0.4 mL·mL﹣1 and the injection volume 2 μl. The retention time for amlodipine, hydrochlorothiazide and losartan was found to be 3.7, 2.5 and 3.9 min, respectively. The developed method was found to be linear over the concentration range of 50 - 300 ng·mL﹣1, 125 - 750 ng·mL﹣1 and 500 - 3000 ng·mL﹣1 for AMLO, HCT and LOSAT respectively. The signal intensities obtained in ion mode for amlodipine, hydrochlorothiazide, losartan and telmisartan (IS) they were found to be much higher positive ion mode (M+)﹣ parent ion at m/z, 409.02, 297.97, 422.91 and 515.03, respectively, in QUATTROZQ full scan mass spectra.

Share and Cite:

Tengli, A. , Shivakumar, G. and Gurupadayya, B. (2015) UPLCMS Method Development and Validation of Amlodipine, Hydrochlorthiazide and Losartan in Combined Tablet Dosage Form. American Journal of Analytical Chemistry, 6, 228-238. doi: 10.4236/ajac.2015.63021.

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1] Gupta, K.R., Mahapatra, A.D., Wadodkar, A.R. and Simultaneous, U.V. (2010) Spectrophotometric Determination of Valsartan and Amlodipine in Tablet. International Journal of ChemTech Research, 2, 551-556.
[2] Pournima, P., Vaishali, B. and Harinath, M. (2011) Spectrophotometric Method for Simultaneous Determination of Olmesartan Medoxomil and Amlodipine Besylate from Tablet Dosage Form. International Journal of Current Pharmaceutical Research, 3, 74-79.
[3] Gazy, A.A.K. (2004) Determination of Amlodipine Besylate by Adsorptive Square-Wave Anodic Stripping Voltammetry on Glassy Carbon Electrode in Tablets and Biological Fluids. Talanta, 62, 575-582.
http://dx.doi.org/10.1016/j.talanta.2003.08.025
[4] Bhatt, J., Singh, S. and Subbaiah, G. (2007) A Rapid and Sensitive Liquid Chromatography-Tandem Mass Spectrometry Method for the Estimation of Amlodipine in Human Plasma. Biomedical Chromatography, 21, 169-175.
http://dx.doi.org/10.1002/bmc.730
[5] Nirogi, R.V., Kandikere, V.N. and Mudigonda, K. (2006) Sensitive and Rapid Liquid Chromatography/Tandem Mass Spectrometry Assay for the Quantification of Amlodipine in Human Plasma. Biomedical Chromatography, 20, 833.
http://dx.doi.org/10.1002/bmc.600
[6] Devi, R., Srinivas, K. and Nagi Reddy, N. (2010) Simultaneous Determination and Stability Evaluation of Amlodipine Besylate and Valsartan in Rat Plasma by RP-HPLC Method. International Journal of Biopharmaceutics, 1, 31-38.
[7] Santaji, N., Vangala Reddy, R. and Durga Rao, D. (2011) Rapid Simultaneous Determination of Telmisartan, Amlodipine Besylate and Hydrochlorothiazide in a Combined Poly Pill Dosage Form by Stability-Indicating Ultra Performance Liquid Chromatography. Scientia Pharmaceutica, 79, 69-84.
http://dx.doi.org/10.3797/scipharm.1006-10
[8] Zarghi, A., Foroutan, S.M. and Shafaati, A. (2005) Validated HPLC Method for Determination of Amlodipine in Human Plasma and Its Application to Pharmacokinetic Studies. Il Farmaco, 60, 789-792.
http://dx.doi.org/10.1016/j.farmac.2005.06.012
[9] Beresford, A.P., Macrae, P.V. and Stopher, D.A. (1987) Analysis of Amlodipine in Haman Plasma by Gas Chromatography. Journal of Chromatography, 420, 178-183.
http://dx.doi.org/10.1016/0378-4347(87)80170-6
[10] Vekariya, N.R., Patel, M.B. and Patel, G.F. (2009) Development and Validation of TLC-Densitometry Method for Simultaneous Determination of Telmisartan and Amlodipine Besylate in Bulk and Tablets. Journal of Young Pharmacist, 1, 259-263.
[11] Argekar, A.P. and Powar, S.G. (2000) Simultaneous Determination of Atenolol and Amlodipine in Tablets by High-Performance Thin-Layer Chromatography. Journal of Pharmaceutical and Biomedical Analysis, 21, 1137-1142.
http://dx.doi.org/10.1016/S0731-7085(99)00210-1
[12] Sidika, E., Sevil Muge, C. and Sedef, A. (2003) Simultaneous Determination of Moexipril Hydrochloride and Hydro-chlorothiazide in Tablets by Derivative Spectrophotometric and High-Performance Liquid Chromatographic Methods. Journal of Pharmaceutical and Biomedical Analysis, 33, 505-511.
http://dx.doi.org/10.1016/S0731-7085(03)00252-8
[13] Bhatia, N.M., Bhatia, M.S. and Choudhari, P.B. (2010) Development and Validation of Spectrophotometric and Ion Pair Chromatographic Technique for Estimation of Valsartan and Hydrochlorothiazide. Journal of Pharmaceutical Research and Health Care, 2, 2-14.
[14] Dhandapani, B., Thirumoorthy, N. and Jose Prakash, D. (2010) Development and Validation for the Simultaneous Quantification of Nebivolol Hydrochloride and Hydrochlorothiazide by UV Spectroscopy, RP-HPLC and HPTLC in Tablets. E-Journal of Chemistry, 7, 341-348.
http://dx.doi.org/10.1155/2010/483495
[15] El-Gindy, A., Ahmed, A. and Abdel-Fattah, L. (2001) Application of LC and HPTLC-Densitometry for the Simultaneous Determination of Benazepril Hydrochloride and Hydrochlorothiazide. Journal of Pharmaceutical and Biomedical Analysis, 25, 171-179.
http://dx.doi.org/10.1016/S0731-7085(00)00480-5
[16] Morra, P.V., Davita, P.C. and Vincenti, M. (2006) Fast Gas Chromatographic/Mass Spectrometric Determination of Diuretics and Masking Agents in Human Urine Development and Validation of a Productive Screening Protocol for Antidoping Analysis. Journal of Chromatography A, 1135, 219-229.
http://dx.doi.org/10.1016/j.chroma.2006.09.034
[17] Jayaseelan, S., Rajasekar, M. and Ganesh, S. (2010) RP-HPLC Method Development and Validation for Simultaneous Estimation of Losartan Potassium, Amlodipine Besilate and Hydrochlorthiazide in Tablet Dosage Form. Scholars Research Library Der Pharma Chemica, 2, 31-36.
[18] Safeer, K., Anbarasi, B. and Senthil Kumar, N. (2010) Analytical Method Development and Validation of Amlodipine and Hydrochlorothiazide in Combined Dosage Form by RP-HPLC. International Journal of ChemTech Research, 2, 21-25.
[19] Gao, F., Zhang, M.F., Cui, X.Y., Wang, Z.H., Sun, Y.T. and Gu, J.K. (2010) Simultaneous Quantitation of Hydrochlorothiazide and Metoprolol in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry. Journal of Pharmaceutical and Biomedical Analysis, 52, 149-154.
http://dx.doi.org/10.1016/j.jpba.2009.12.012
[20] Martoan, M.E., Hernaandez, O.M. and Jimeanez, A.I. (1999) Partial Least-Squares Method in Analysis by Differential Pulse Polarography Simultaneous Determination of Amiloride and Hydrochlorothiazide in Pharmaceutical Preparations. Analytica Chimica Acta, 381, 247-256.
http://dx.doi.org/10.1016/S0003-2670(98)00732-6
[21] Giuseppe, C., Giancarlo, P. and Pietro, M. (2000) Simultaneous Determination of Losartan and Hydrochlorothiazide in Tablets by High-Performance Liquid Chromatography. Journal of Pharmaceutical and Biomedical Analysis, 23, 185-189.
http://dx.doi.org/10.1016/S0731-7085(00)00268-5
[22] Maria del Rosario, B., Yaritza, C. and Sabrina, C. (2009) Determination of Losartan, Telmisartan, and Valsartan by Direct Injection of Human Urine into a Column-Switching Liquid Chromatographic System with Fluorescence Detection. Journal of Pharmaceutical and Biomedical Analysis, 50, 194-199.
[23] Mehdi, A., Maryam, K. and Mehdi, B. (2004) Derivative Spectrophotometric Method for Determination of Losartan in Pharmaceutical Formulations. Iranian Journal of Pharmacology & Therapeutics, 3, 21-25.
[24] Olga, C.L., Igor, G.L. and Hugo, J.S. (2003) Development and Validation of an UV Derivative Spectrophotometric Determination of Losartan Potassium in Tablets. Journal of Pharmaceutical and Biomedical Analysis, 33, 175-180.
http://dx.doi.org/10.1016/S0731-7085(03)00347-9
[25] Ali Asghar, E. and Reza, H. (2008) Determination of Losartan and Triamterene in Pharmaceutical Compounds and Urine Using Cathodic Adsorptive Stripping. Analytical Sciences, 24, 1449-1454.
http://dx.doi.org/10.2116/analsci.24.1449
[26] Williams, R.C., Alasandro, M.S. and Fasone, V.L. (1996) Comparison of Liquid Chromatography, Capillary Electrophoresis and Super-Critical Fluid Chromatography in the Determination of Losartan Potassium Drug Substance in Cozaar® Tablets. Journal of Pharmaceutical and Biomedical Analysis, 14, 1539-1546.
http://dx.doi.org/10.1016/0731-7085(96)01740-2
[27] Hillaert, S. and Van den Bossche, W. (2003) Simultaneous Determination of Hydrochlorothiazide and Several Angiotensin-II-Receptor Antagonists by Capillary Electrophoresis. Journal of Pharmaceutical and Biomedical Analysis, 31, 329-339.
http://dx.doi.org/10.1016/S0731-7085(02)00643-X
[28] Williams, R.C., Alasandro, M.S. and Fasone, V.L. (1996) Comparison of Liquid Chromatography, Capillary Electrophoresis and Super-Critical Fluid Chromatography in the Determination of Losartan Potassium Drug Substance in Cozaar® Tablets. Journal of Pharmaceutical and Biomedical Analysis, 14, 1539-1546.
http://dx.doi.org/10.1016/0731-7085(96)01740-2
[29] Sathe, S.R. and Bari, S.B. (2007) Simultaneous Analysis of Losartan Potassium, Atenolol, and Hydrochlorothiazide in Bulk and in Tablets by HPTL Chromatography with UV Absorption Densitometry. Acta Chromatographica, 19, 270-278.
[30] Mahadik, K.R., Kadam, S.S., Agrawal, H. and Kaul, N. (2002) Simultaneous HPTLC Estimation of Amlodipine Besylate and Losartan Potassium in Tablets Dosage Forms. International Pharmaceutical Federation World Congress, 68, 38.
[31] Habib, H.I., Weshahy, S.A. and Toubar, S. (2008) Cathodic Stripping Voltammetric Determination of Losartan in Bulk and Pharmaceutical Products. Portugaliae Electrochimica Acta, 26, 315-324.
http://dx.doi.org/10.4152/pea.200804315
[32] Zhao. Z., Wang, Q., Tsai, E.W., Qin, X. and Ip, D. (1999) Identification of Losartan Degradates in Stressed Tablets by LC-MS and LC-MS/MS. Journal of Pharmaceutical and Biomedical Analysis, 20, 129-136.
http://dx.doi.org/10.1016/S0731-7085(99)00004-7

  
comments powered by Disqus

Copyright © 2020 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.