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

• Autorzy: Desai P. R. , Mehta P. J. , Ojha S. K. , Chokshi A. B.

Identyfikatory

DOI

10.1556/1326.2017.00273

• 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.

Słowa kluczowe

EN

Ezetimibe; simvastatin; high-performance liquid chromatography; impurity; method validation

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2018
• Tom: Vol. 30, no. 2
• Strony: 85--94
• Opis fizyczny: Bibliogr. 28 poz., rys., tab.

Twórcy

autor

Desai P. R.

• Department of Analytical Research, PTC-Moraiya, Zydus Cadila Healthcare Limited, NH 8A, Moraiya-382213, Gujarat, India

autor

Mehta P. J.

• Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedbad-382481, Gujarat, India

autor

Ojha S. K.

• Department of Analytical Research, PTC-Moraiya, Zydus Cadila Healthcare Limited, NH 8A, Moraiya-382213, Gujarat, India

autor

Chokshi A. B.

• Ramanbhai Patel College of Pharmacy, CHARUSAT, Changa, 388421, Gujarat, India

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Uwagi

PL

Opracowanie rekordu w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2018).