5
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Simultaneous determination of telmisartan and amlodipine in human plasma by LC–MS/MS and its application in a human pharmacokinetic study

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          A rapid and sensitive liquid chromatography–tandem mass spectrometric (LC–MS/MS) assay method has been developed and fully validated for the simultaneous quantification of telmisartan and amlodipine in human plasma. Carbamazepine was used as an internal standard. Analytes and the internal standard were extracted from human plasma by solid-phase extraction technique using Waters Oasis ® HLB 1 cm 3 (30 mg) extraction cartridge. The reconstituted samples were chromatographed on a Hypurity advance C 18 column (50 mm×4.6 mm, 5 μm) using a mixture of acetonitrile–5 mM ammonium acetate buffer (pH-4.0) (50:50, v/v) as the mobile phase at a flow rate of 0.8 mL/min. The calibration curve obtained was linear ( r≥0.99) over the concentration range of 2.01–400.06 ng/mL for telmisartan and 0.05–10.01 ng/mL for amlodipine. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 400 human plasma samples per day. The proposed method was found to be applicable to clinical studies.

          Related collections

          Most cited references27

          • Record: found
          • Abstract: not found
          • Article: not found

          Nonpeptide angiotensin II receptor antagonists: the next generation in antihypertensive therapy.

            Bookmark
            • Record: found
            • Abstract: found
            • Article: found

            Pharmacokinetics and Pharmacodynamics of Amlodipine

            Amlodipine is a low-clearance, dihydropyridine calcium antagonist. The slow rate of elimination (elimination half-life of 40-60 h) confers several pharmacokinetic characteristics that are not seen with other calcium-antagonist drugs. It has high oral bioavailability (60-80%) and accumulates to a steady-state with once-daily administration over a period of 1-1 ½ weeks. Fluctuation of plasma drug concentration between doses is between 20 and 25% when once-daily dosing is used. Onset of effect is gradual after oral administration which is due, in part, to an intermediate rate of drug absorption (peak plasma drug concentration occurs 6-8 h after dosing) and perhaps also to the physicochemical characteristics of the drug-cell membrane-receptor interaction. The pharmacodynamic profile of the drug in hypertensive patients is consistent with the disposition of the drug. After single doses, blood pressure decreases gradually over 4-8 h and may slowly return to baseline over 24-72 h. No change in heart rate is noted after the dose as the onset is gradual and physiological reflexes are not activated. During chronic, oral, once-daily dosing blood pressure is decreased from pretreatment baseline with little fluctuation over the 24-hour dose interval. Discontinuation of amlodipine treatment results in a slow return of blood pressure to baseline over 7-10 days, with no evidence of a ‘rebound’ effect. Amlodipine is a low-clearance, dihydropyridine calcium antagonist which is effective for the treatment of hypertension and angina pectoris with once-daily dosing.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Determination and pharmacokinetic study of amlodipine in human plasma by ultra performance liquid chromatography-electrospray ionization mass spectrometry.

              A novel, specific and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method was developed for the determination and pharmacokinetic study of amlodipine in human plasma. The analysis was carried out on an ACQUITY UPLC BEH C(18) column (50 mm x 2.1 mm, i.d., 1.7 microm) with gradient elution at a flow-rate of 0.35 ml/min. The mobile phase was water and acetonitrile under gradient conditions (both containing 0.3% formic acid) and nimodipine was used as the internal standard. Detection was performed on a triple-quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode via Turbo ion spray ionization (ESI). Linear calibration curves were obtained over the concentration range 0.15-16.0 ng/ml, with a lower limit of quantification of 0.15 ng/ml. The intra- and inter-day precision (R.S.D.) values were below 15% and the accuracy (R.E.) was -2.3% to 6.9% at all three QC levels. The method was used to support clinical pharmacokinetic studies of amlodipine in healthy volunteers following oral administration.
                Bookmark

                Author and article information

                Contributors
                Journal
                J Pharm Anal
                J Pharm Anal
                Journal of Pharmaceutical Analysis
                Xi'an Jiaotong University
                2095-1779
                2214-0883
                04 April 2012
                October 2012
                04 April 2012
                : 2
                : 5
                : 319-326
                Affiliations
                [a ]Research Studies, Rayalaseema University, Kurnool 518002, India
                [b ]Wellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, India
                [c ]BioPolymer and Thermophysical Lab, Department of Chemistry, Sri Venkateswara University, Tirupati 517502, India
                [d ]Analytical and Environmental Chemistry Division, Department of Chemistry, Sri Venkateswara University, Tirupati 517502, India
                Author notes
                [* ]Corresponding author. Tel.: +91 9393600444. pvchem01@ 123456gmail.com
                Article
                S2095-1779(12)00048-2
                10.1016/j.jpha.2012.03.008
                5760765
                0486afe5-6c69-4801-bddf-0f4267ffa545
                © 2012 Xi'an Jiaotong University

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

                History
                : 4 January 2012
                : 22 March 2012
                Categories
                Article

                telmisartan,amlodipine,human plasma,solid-phase extraction,lc–ms/ms,pharmacokinetics

                Comments

                Comment on this article