Qun Xu. Advancing USP compendial methods for fixed dose combinations: A case study of metoprolol tartrate and hydrochlorothiazide tablets[J]. Journal of Pharmaceutical Analysis, 2019, 9(2): 77-82.
Citation: Qun Xu. Advancing USP compendial methods for fixed dose combinations: A case study of metoprolol tartrate and hydrochlorothiazide tablets[J]. Journal of Pharmaceutical Analysis, 2019, 9(2): 77-82.

Advancing USP compendial methods for fixed dose combinations: A case study of metoprolol tartrate and hydrochlorothiazide tablets

  • Publish Date: Apr. 10, 2019
  • The current United States Pharmacopeia–National Formulary (USP–NF) includes more than 250 mono-graphs of fixed dose combinations (FDCs), and some of them need to be updated due to incompleteness of impurity profiles and obsolescence of analytical methodologies. A case study of metoprolol tartrate and hydrochlorothiazide tablets is presented to summarize challenges encountered during the USP monograph modernization initiative of FDCs and to highlight an "adoption and adaptation" approach employed for method development. To this end, a single stability-indicating HPLC method was devel-oped to separate the two drug substances and eight related compounds with resolution 2.0 or higher between all critical pairs. Chromatographic separations were achieved on a Symmetry column (C18, 100 mm × 4.6 mm, 3.5 μm) using sodium phosphate buffer (pH 3.0; 34 mM) and acetonitrile as mobile phase in a gradient elution mode. The stability-indicating capability of this method has been demon-strated by analyzing stressed samples of the two drug substances. The developed HPLC method was validated for simultaneous determination of metoprolol tartrate and hydrochlorothiazide and relevant impurities in the tablets. Moreover, the developed method was successfully applied to the analysis of commercial tablet dosage forms and proved to be suitable for routine quality control use. The case study could be used to streamline USP's monograph modernization process of FDCs and strengthen compendial procedures.
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    1. Afonso Urich, J.A., Marko, V., Boehm, K. et al. Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles. Scientia Pharmaceutica, 2024, 92(2): 22. doi:10.3390/scipharm92020022
    2. Vilela de Oliveira, C., Peron, A., Rashid, A. et al. Validation, measurement uncertainty estimation and evaluation of UHPLC greenness for simultaneous determination of metoprolol tartrate and hydrochlorothiazide in binary tablet. Journal of Taibah University for Science, 2024, 18(1): 2339010. doi:10.1080/16583655.2024.2339010
    3. Urich, J.A.A., Marko, V., Boehm, K. et al. Development and Validation of a Stability Indicating HPLC Method for the Simultaneous Determination of Metformin, Hydrochlorothiazide and Acetylsalicylic Acid in an On-Demand Fixed-Dose Combination Dosage Form. Journal of Analytical Chemistry, 2023, 78(12): 1760-1769. doi:10.1134/S1061934823120195
    4. Jahani, M., Akaberi, M., Heidari, T. et al. Simultaneous determination of mometasone furoate and calcipotriol in a binary mixture by validated HPLC and chemometric-assisted UV spectrophotometric methods and identification of degradation products by LC-MS. Iranian Journal of Basic Medical Sciences, 2023, 26(1): 37-47. doi:10.22038/IJBMS.2022.65436.14396
    5. Jahani, M., Fazly Bazzaz, B.S., Akaberi, M. et al. Recent Progresses in Analytical Perspectives of Degradation Studies and Impurity Profiling in Pharmaceutical Developments: An Updated Review. Critical Reviews in Analytical Chemistry, 2023, 53(5): 1094-1115. doi:10.1080/10408347.2021.2008226
    6. Tiris, G., Mehmandoust, M., Lotfy, H.M. et al. Simultaneous determination of hydrochlorothiazide, amlodipine, and telmisartan with spectrophotometric and HPLC green chemistry applications. Chemosphere, 2022. doi:10.1016/j.chemosphere.2022.135074
    7. Jeličić, M.-L., Brusač, E., Klarić, D.A. et al. Physicochemical compatibility investigation of mesalazine and folic acid using chromatographic and thermoanalytical techniques. Pharmaceuticals, 2020, 13(8): 1-15. doi:10.3390/ph13080187
    8. Yıldırım, S., Erkmen, C., Uslu, B. Novel Trends in Analytical Methods for β-Blockers: An Overview of Applications in the Last Decade. Critical Reviews in Analytical Chemistry, 2020. doi:10.1080/10408347.2020.1791043

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