Quality by design approach for simultaneous determination of original active pharmaceutical ingredient quinabut and its impurities by using HPLC. Message 1
In: Pharmacia 68((1)) 79-87, 2021
academicJournal
Zugriff:
Aim. The aim of study was to develop and validate a simple, highly robust (quality by design (QbD) approach), precise and accurate method using high performance liquid chromatography for the simultaneous determination of original active pharmaceutical ingredient Quinabut and its impurities. Materials and methods. Experiments were performed on a Shimadzu LC-20 Prominence HPLC separation module, equipped with a quaternary gradient pump, temperature controlled column heater, sampler manager and diode array detector and LC-20 Chemstation for data analysis (Shimadzu Corporation, Japan). Same software was used for data acquisition and processing of results. X-Terra RP18 (4.6×150 mm, 5 μm) analytical chromatographic column provided by Waters Corporation (Milford, MA) was used for all optimization experiments. Mobile phase A: acetonitrile R. Mobile phase B: 0.025 M phosphate buffer solution. Samples were chromatographed in gradient mode. Flow rate of the mobile phase: 0.7 mL/min. Column temperature: 40 °С. Detection: at 233 nm wavelength. Injection volume: 50 μl. Results. Screening of the influence of four chromatographic factors on different chromatographic responses was performed as the initial step of analytical method optimization. A randomized fractional factorial experimental design (24–1) of resolution IV with central point was used. Buffer pH, amount of acetonitrile in mobile phase A, the amount of phosphate buffer solution in mobile phase B and column temperature were selected as factors of interest, and were used to generate the fractional factorial experimental design. Linearity was established in the range of LOQ level to 0.2% having regression coefficients 0.9977. Calibration curve – y = 0.0132 + 0.9902. Since Δt for the content of quinabut is less than max δ, the technique is stable over time. The possibility of contamination of the sample by decomposition products by keeping it under stressful conditions (irradiation of the substance solution with UV light (UV irradiation with mercury lamp light); acid ...
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Quality by design approach for simultaneous determination of original active pharmaceutical ingredient quinabut and its impurities by using HPLC. Message 1
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Autor/in / Beteiligte Person: | Golembiovska, Оlena ; Voskoboinik, Oleksii ; Berest, Galina ; Kovalenko, Sergiy ; Logoyda, Liliya |
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Zeitschrift: | Pharmacia 68((1)) 79-87, 2021 |
Veröffentlichung: | Bulgarian Pharmaceutical Scientific Society, 2021 |
Medientyp: | academicJournal |
DOI: | 10.3897/pharmacia.68.e50704 |
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