Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography
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A liquid chromatography method is reported for the determination of diclofenac potassium and its impurities using Quality by Design criteria. Central composite design was used for the investigation of the influence of critical parameters on performance that included the methanol concentration in the mobile phase, the pH of the aqueous phase, and the potassium dihydrogen phosphate concentration in the aqueous phase. Mathematical models enabled theoretical examination of experimental space to achieve maximal separation in minimal analysis time. A Monte Carlo simulation was used to evaluate the risk of uncertainty in model predictions, to adjusting process parameters, and to identify design space. Fractional factorial design was employed for robustness testing and method was fully validated. Optimal conditions were a C18 150mmx4.6mm, 5 mu m particle size column; a methanol -68.3mmolL(-1) potassium dihydrogenphosphate (68.7:31.3, v/v) mobile phase at pH 3.0, a flow rate of 1mL min(-1), a c...olumn temperature of 25 degrees C, and ultraviolet detection at 254nm.
Source:
Analytical Letters, 2016, 49, 4, 445-457Publisher:
- Taylor & Francis Inc, Philadelphia
Funding / projects:
- Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-MESTD-Basic Research (BR or ON)-172052)
Note:
- This is peer-reviewed version of the following article: Tumpa, A.; Miladinović, T.; Rakić, T.; Stajić, A.; Jančić-Stojanović, B. Quality by Design Determination of Diclofenac Potassium and Its Impurities by High-Performance Liquid Chromatography. Anal. Lett. 2016, 49 (4), 445–457. https://doi.org/10.1080/00032719.2015.1075131
DOI: 10.1080/00032719.2015.1075131
ISSN: 0003-2719
WoS: 000369871800001
Scopus: 2-s2.0-84956603382
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https://farfar.pharmacy.bg.ac.rs/handle/123456789/2567https://farfar.pharmacy.bg.ac.rs/handle/123456789/3444
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PharmacyTY - JOUR AU - Tumpa, Anja AU - Miladinović, Tamara AU - Rakić, Tijana AU - Stajić, Ana AU - Jančić-Stojanović, Biljana PY - 2016 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2567 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3444 AB - A liquid chromatography method is reported for the determination of diclofenac potassium and its impurities using Quality by Design criteria. Central composite design was used for the investigation of the influence of critical parameters on performance that included the methanol concentration in the mobile phase, the pH of the aqueous phase, and the potassium dihydrogen phosphate concentration in the aqueous phase. Mathematical models enabled theoretical examination of experimental space to achieve maximal separation in minimal analysis time. A Monte Carlo simulation was used to evaluate the risk of uncertainty in model predictions, to adjusting process parameters, and to identify design space. Fractional factorial design was employed for robustness testing and method was fully validated. Optimal conditions were a C18 150mmx4.6mm, 5 mu m particle size column; a methanol -68.3mmolL(-1) potassium dihydrogenphosphate (68.7:31.3, v/v) mobile phase at pH 3.0, a flow rate of 1mL min(-1), a column temperature of 25 degrees C, and ultraviolet detection at 254nm. PB - Taylor & Francis Inc, Philadelphia T2 - Analytical Letters T1 - Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography VL - 49 IS - 4 SP - 445 EP - 457 DO - 10.1080/00032719.2015.1075131 ER -
@article{ author = "Tumpa, Anja and Miladinović, Tamara and Rakić, Tijana and Stajić, Ana and Jančić-Stojanović, Biljana", year = "2016", abstract = "A liquid chromatography method is reported for the determination of diclofenac potassium and its impurities using Quality by Design criteria. Central composite design was used for the investigation of the influence of critical parameters on performance that included the methanol concentration in the mobile phase, the pH of the aqueous phase, and the potassium dihydrogen phosphate concentration in the aqueous phase. Mathematical models enabled theoretical examination of experimental space to achieve maximal separation in minimal analysis time. A Monte Carlo simulation was used to evaluate the risk of uncertainty in model predictions, to adjusting process parameters, and to identify design space. Fractional factorial design was employed for robustness testing and method was fully validated. Optimal conditions were a C18 150mmx4.6mm, 5 mu m particle size column; a methanol -68.3mmolL(-1) potassium dihydrogenphosphate (68.7:31.3, v/v) mobile phase at pH 3.0, a flow rate of 1mL min(-1), a column temperature of 25 degrees C, and ultraviolet detection at 254nm.", publisher = "Taylor & Francis Inc, Philadelphia", journal = "Analytical Letters", title = "Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography", volume = "49", number = "4", pages = "445-457", doi = "10.1080/00032719.2015.1075131" }
Tumpa, A., Miladinović, T., Rakić, T., Stajić, A.,& Jančić-Stojanović, B.. (2016). Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography. in Analytical Letters Taylor & Francis Inc, Philadelphia., 49(4), 445-457. https://doi.org/10.1080/00032719.2015.1075131
Tumpa A, Miladinović T, Rakić T, Stajić A, Jančić-Stojanović B. Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography. in Analytical Letters. 2016;49(4):445-457. doi:10.1080/00032719.2015.1075131 .
Tumpa, Anja, Miladinović, Tamara, Rakić, Tijana, Stajić, Ana, Jančić-Stojanović, Biljana, "Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography" in Analytical Letters, 49, no. 4 (2016):445-457, https://doi.org/10.1080/00032719.2015.1075131 . .