144
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Rapid Simultaneous Determination of Telmisartan, Amlodipine Besylate and Hydrochlorothiazide in a Combined Poly Pill Dosage Form by Stability-Indicating Ultra Performance Liquid Chromatography

      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 simple, precise and rapid stability-indicating ultra-performance liquid chromatography (UPLC) method is developed for the simultaneous quantitative determination of Telmisartan, Amlodipine besylate and Hydrochlorothiazide from their innovative poly pill combination drug product in the presence of degradation products. It involves a 100 mm x 2.1 mm, 1.7 μm C-18 column. The separation is achieved on a simple gradient method. The mobile phase A contains a mixture of sodium perchlorate buffer pH 3.2 (0.053M): acetonitrile in the ratio 90:10, v/v, and mobile B contains a mixture of sodium perchlorate buffer pH 3.2 (0.053M): acetonitrile in the ratio 20:80, v/v. The flow rate is 0.6 mL min −1 and the column temperature is maintained at 55°C.The gradient program (T/%B) is set as 0/5, 1.2/5, 1.6/40, 4/40, 4.1/5 and 4.5/5. The detector wavelength is 271 nm for Hydrochlorothiazide and Telmisartan and 237 nm for Amlodipine. The retention times of Telmisartan, Amlodipine, and Hydrochlorothiazide are 3.6 minutes, 3.2 minutes and 0.9 minutes; respectively. The total runtime for the separation of the three active compounds and their degradation products is 4.5 minutes. The described method is validated with respect to system suitability, specificity, linearity, precision and accuracy. The precision of the assay method is evaluated by carrying out six independent assays of T, A and H (0.032 mg mL −1 of T, 0.004 mg mL −1 of A, 0.01 mg mL −1 of H). The accuracy of the method is evaluated in triplicate at three concentration levels, i.e. 50%, 100% and 150% of target test concentration (0.64 mg mL −1 of T, 0.08 mg mL −1 of A, 0.2 mg mL −1 of H). The described method is linear over the range, 16 to 48 μg mL −1 for T, 2 to 6 μg mL −1A and 5 to 15 μg mL −1 for H. The method is fast and suitable for high-throughput analysis allowing the analysis of about 250 samples per working day.

          Related collections

          Most cited references20

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

          Development of validated stability-indicating assay methods--critical review.

          This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products. The shortcomings of reported methods with respect to regulatory requirements are highlighted. A systematic approach for the development of stability-indicating methods is discussed. Critical issues related to development of SIAMs, such as separation of all degradation products, establishment of mass balance, stress testing of formulations, development of SIAMs for combination products, etc. are also addressed. The applicability of pharmacopoeial methods for the analysis of stability samples is discussed. The requirements of SIAMs for stability study of biotechnological substances and products are also touched upon.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Stability indicating RP-HPLC method for simultaneous determination of amlodipine and benazepril hydrochloride from their combination drug product.

            A stability indicating reversed-phase HPLC method has been developed and subsequently validated for simultaneous estimation of amlodipine (AM) present as amlodipine besylate (AB), and benazepril hydrochloride (BH) from their combination product. The proposed RP-HPLC method utilizes a Zorbax SB C18, 5 microm, 250 mm x 4.6 mm i.d. column, mobile phase consisting of phosphate buffer and acetonitrile in the proportion of 65:35 (v/v) with apparent pH adjusted to 7.0, and UV detection at 240 nm using a photodiode array detector. AB, BH, and their combination drug product were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analysed by the proposed method. Peak homogeneity data of AM and BH peaks obtained using photodiode array detector, in the stressed sample chromatograms, demonstrated the specificity of the method for their estimation in presence of degradants. The described method was linear over a range of 6-14 microg/ml for AM and 12-28 microg/ml for BH. The mean recoveries were 99.91 and 100.53% for AM and BH, respectively. F-test and t-test at 95% confidence level were used to check the intermediate precision data obtained under different experimental setups; the calculated value was found to be less than critical value.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Simultaneous determination of hydrochlorothiazide and several angiotensin-II-receptor antagonists by capillary electrophoresis.

              We have investigated the capability of the capillary zone electrophoretic (CZE) and micellar electrokinetic capillary chromatographic (MEKC) methods to simultaneously separate hydrochlorothiazide and six angiotensin-II-receptor antagonists (ARA-IIs): candesartan, eprosartan mesylate, irbesartan, losartan potassium, telmisartan, and valsartan. The CZE and MEKC methods are suitable for the qualitative and quantitative determination of combined HCT/ARA-IIs in pharmaceutical formulations. Depending on the ARA-II, at least one of the two methods can be used for each combination. The two methods have been validated in terms of their linearity of response, reproducibility, and accuracy.
                Bookmark

                Author and article information

                Journal
                Sci Pharm
                Scientia Pharmaceutica
                Scientia Pharmaceutica
                Österreichische Apotheker-Verlagsgesellschaft
                0036-8709
                2218-0532
                March 2011
                2011
                4 January 2011
                : 79
                : 1
                : 69-84
                Affiliations
                [1 ]Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
                [2 ]Department of Chemistry, J.N.T. University, Kukatpally, Hyderabad-500 072, A.P., India
                Author notes
                [* ]Corresponding author. E-mails: nalwadesu@ 123456drreddys.com or santajin@ 123456rediffmail.com (S. Nalwade)
                Article
                scipharm_2011_79_69
                10.3797/scipharm.1006-10
                3097503
                21617773
                39006ba7-30f3-4fca-b5ec-f7cd9cd2f698
                © Nalwade et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m. b. H., Vienna, Austria.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 24 June 2010
                : 4 January 2011
                Categories
                Research Article

                Pharmacology & Pharmaceutical medicine
                uplc,stability,simultaneous,method development,degradation,validation

                Comments

                Comment on this article