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Simultaneous quantification of related substances of ezetimibe and simvastatin in combined dosage form using a novel stability-indicating liquid chromatographic method

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A novel, simple, robust, and rapid reversed-phased high-performance liquid chromatographic method has been developed for the separation and quantitative determination of the related substances of ezetimibe and simvastatin in combined dosage forms. Successful separation of the drug from the process-related impurities and degradation products formed under stress conditions was achieved on Inertsil ODS-3V (150 × 4.6 mm, 5.0 μm) column. The gradient liquid chromatography (LC) method employs solution A and solution B as mobile phase. The solution A contains 0.1% orthophosphoric acid solution in water, and solution B contains 0.1% orthophosphoric acid solution in acetonitrile. Flow rate was monitored at 2.0 mL/min, and the ultraviolet (UV) detection, at 238 nm. In forced degradation studies, the effect of acid, base, oxidation, UV light, and temperature was investigated, showing that good resolution between the peaks corresponds to process-related impurities and degradation products from both analyte. The performance of the method was validated according to the present International Conference on Harmonization (ICH) guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness, and robustness. To the best of our knowledge, a rapid LC method, which separates all the impurities of ezetimibe and simvastatin in combined dosage forms, disclosed in this investigation was not published elsewhere.
Rocznik
Strony
85--94
Opis fizyczny
Bibliogr. 28 poz., rys., tab.
Twórcy
autor
  • Department of Analytical Research, PTC-Moraiya, Zydus Cadila Healthcare Limited, NH 8A, Moraiya-382213, Gujarat, India
autor
  • Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedbad-382481, Gujarat, India
autor
  • Department of Analytical Research, PTC-Moraiya, Zydus Cadila Healthcare Limited, NH 8A, Moraiya-382213, Gujarat, India
  • Ramanbhai Patel College of Pharmacy, CHARUSAT, Changa, 388421, Gujarat, India
Bibliografia
  • [1] Desager, J.-P. ; Horsmans, Y. Clin. Pharmacokinet. 1996, 31, 348–371.
  • [2] O'Neil Marryadele, J. The Merck Index an Encylopedia of Chemiclas, Drugs and Biologicals. Marck research laboratories: 2006.
  • [3] Stancu, C. ; Sima, A. J. Cell. Mol. Med. 2001, 5, 378–387.
  • [4] Armitage, J. The Lancet 370, 1781–1790.
  • [5] Grigore, L. ; Norata, G. D. ; Catapano, A. L. Vasc. Health Risk Manage. 2008, 4, 267.
  • [6] Darkes, M. J. M. ; Poole, R. M. ; Goa, K. L. Ezetimibe. Am. J. Cardiovasc. Drugs 2003, 3, 67–76.
  • [7] Davis, H. R. ; Hoos, L. M. ; Tetzloff, G. ; Maguire, M. ; Zhu, L.-J. ; Graziano, M. P. ; Altmann, S. W. Arterioscler., Thromb., Vasc. Biol. 2007, 27, 841.
  • [8] Kastelein, J. J. P. ; Sankatsing, R. R. Int. J. Clin. Pract. 2005, 59, 1464–1471.
  • [9] Mauro, V. F. ; Tuckerman, C. E. Ann. Pharmacother. 2003, 37, 839–848.
  • [10] Carlucci, G. ; Mazzeo, P. Il Farmaco (Pavia) 1992, 47, 817–823.
  • [11] Kim, B. C. ; Ban, E. ; Park, J. S. ; Song, Y. K. ; Kim, C. K. J. Liq. Chromatogr. Relat. Technol. 2004, 27, 3089–3102.
  • [12] Ochiai, H. ; Uchiyama, N. ; Imagaki, K. ; Hata, S. ; Kamei, T. J. Chromatogr. B: Biomed. Sci. Appl. 1997, 694, 211–217.
  • [13] Jemal, M. ; Ouyang, Z. ; Powell, M. L. J. Pharm. Biomed. Anal. 2000, 23, 323–340.
  • [14] Miao, X.-S. ; Metcalfe, C. D. J. Chromatogr. A 2003, 998, 133–141.
  • [15] Yang, H. ; Feng, Y. ; Luan, Y. J. Chromatogr. B 2003, 785, 369–375.
  • [16] Zhang, N. ; Yang, A. ; Rogers, J. D. ; Zhao, J. J. J. Pharm. Biomed. Anal. 2004, 34, 175–187.
  • [17] Morris, M. J. ; Gilbert, J. D. ; Hsieh, J. Y. K. ; Matuszewski, B. K. ; Ramjit, H. G. ; Bayne, W. F. Biol. Mass Spectrom. 1993, 22, 1–8.
  • [18] Srinivasu, M. K. ; Raju, A. N. ; Reddy, G. O. J. Pharm. Biomed. Anal. 2002, 29, 715–721.
  • [19] Basavaiah, K. ; Devi, O. Z. Eclética Química 2008, 33, 21–28.
  • [20] Chavhan, V. ; Reddy, K. ; Ahhirao, K. J. App. Pharm. 2014, 6, 55–64.
  • [21] Doshi, A. S. ; Kachhadia, P. K. ; Joshi, H. S. Chromatographia 2008, 67, 137–142.
  • [22] Singh, S. ; Singh, B. ; Bahuguna, R. ; Wadhwa, L. ; Saxena, R. J. Pharm. Biomed. Anal. 2006, 41, 1037–1040.
  • [23] Dash, R. N. ; Habibuddin, M. ; Humaira, T. ; Patel, A. A. J. Liq. Chromatogr. Relat. Technol. 2015, 38, 874–885.
  • [24] Li, S. ; Liu, G. ; Jia, J. ; Li, X. ; Yu, C. J. Pharm. Biomed. Anal. 2006, 40, 987–992.
  • [25] Oswald, S. ; Scheuch, E. ; Cascorbi, I. ; Siegmund, W. J. Chromatogr. B 2006, 830, 143–150.
  • [26] Sistla, R. ; Tata, V. S. S. K. ; Kashyap, Y. V. ; Chandrasekar, D. ; Diwan, P. V. J. Pharm. Biomed. Anal. 2005, 39, 517–522.
  • [27] Guideline, I. H. T. Stability testing of new drug substances and products. Q1A (R2), current step 2003, 4.
  • [28] Guideline, I. H. T. Validation of analytical procedures: text and methodology. Q2 (R1) 2005, 1.
Uwagi
PL
Opracowanie rekordu w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2018).
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-852f964d-f8c1-4b4c-9c17-56273840ef06
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