Systematical approach in evaluation of LC method for determination of raloxifene hydrochloride and its impurities employing experimental design
2013
Autori
Jančić-Stojanović, BiljanaRakić, Tijana
Slavković, B
Kostić, Nada
Vemić, Ana
Malenović, Anđelija
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
Method validation presents a detailed investigation of analytical method and provision of the evidence that the method, when correctly applied, produces results that fit to the purpose. In order to achieve the method validation scope efficiently, experimental design presents a very useful tool. The greatest benefits of such approach could be seen in robustness testing through the provision of very useful data about the control of the chromatographic system during the routine application. In this paper, robustness testing of the LC method proposed for the determination of raloxifene hydrochloride and its four impurities was done employing Plackett-Burman design. Applying this design, the effect of five real factors (acetonitrile content, sodium dodecyl sulfate content, column temperature, pH of the mobile phase and flow rate) on the corresponding resolution factors was investigated through twelve experiments. Furthermore, the insignificance intervals for significant factors were calcula...ted and the parameters for system suitability tests were defined. Eventually, the other validation parameters were tested and the effectiveness of the proposed analytical method with a high degree of accuracy was confirmed.
Ključne reči:
Experimental design / Impurities / Liquid chromatography / Method validation / Raloxifene hydrochlorideIzvor:
Journal of Pharmaceutical Analysis, 2013, 3, 1, 45-52Izdavač:
- Xi'an Jiaotong University
Finansiranje / projekti:
- Modelovanje različitih hromatografskih sistema sa hemometrijskim pristupom u farmaceutskoj analizi (RS-MESTD-Basic Research (BR or ON)-172052)
Institucija/grupa
PharmacyTY - JOUR AU - Jančić-Stojanović, Biljana AU - Rakić, Tijana AU - Slavković, B AU - Kostić, Nada AU - Vemić, Ana AU - Malenović, Anđelija PY - 2013 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2025 AB - Method validation presents a detailed investigation of analytical method and provision of the evidence that the method, when correctly applied, produces results that fit to the purpose. In order to achieve the method validation scope efficiently, experimental design presents a very useful tool. The greatest benefits of such approach could be seen in robustness testing through the provision of very useful data about the control of the chromatographic system during the routine application. In this paper, robustness testing of the LC method proposed for the determination of raloxifene hydrochloride and its four impurities was done employing Plackett-Burman design. Applying this design, the effect of five real factors (acetonitrile content, sodium dodecyl sulfate content, column temperature, pH of the mobile phase and flow rate) on the corresponding resolution factors was investigated through twelve experiments. Furthermore, the insignificance intervals for significant factors were calculated and the parameters for system suitability tests were defined. Eventually, the other validation parameters were tested and the effectiveness of the proposed analytical method with a high degree of accuracy was confirmed. PB - Xi'an Jiaotong University T2 - Journal of Pharmaceutical Analysis T1 - Systematical approach in evaluation of LC method for determination of raloxifene hydrochloride and its impurities employing experimental design VL - 3 IS - 1 SP - 45 EP - 52 DO - 10.1016/j.jpha.2012.09.007 ER -
@article{ author = "Jančić-Stojanović, Biljana and Rakić, Tijana and Slavković, B and Kostić, Nada and Vemić, Ana and Malenović, Anđelija", year = "2013", abstract = "Method validation presents a detailed investigation of analytical method and provision of the evidence that the method, when correctly applied, produces results that fit to the purpose. In order to achieve the method validation scope efficiently, experimental design presents a very useful tool. The greatest benefits of such approach could be seen in robustness testing through the provision of very useful data about the control of the chromatographic system during the routine application. In this paper, robustness testing of the LC method proposed for the determination of raloxifene hydrochloride and its four impurities was done employing Plackett-Burman design. Applying this design, the effect of five real factors (acetonitrile content, sodium dodecyl sulfate content, column temperature, pH of the mobile phase and flow rate) on the corresponding resolution factors was investigated through twelve experiments. Furthermore, the insignificance intervals for significant factors were calculated and the parameters for system suitability tests were defined. Eventually, the other validation parameters were tested and the effectiveness of the proposed analytical method with a high degree of accuracy was confirmed.", publisher = "Xi'an Jiaotong University", journal = "Journal of Pharmaceutical Analysis", title = "Systematical approach in evaluation of LC method for determination of raloxifene hydrochloride and its impurities employing experimental design", volume = "3", number = "1", pages = "45-52", doi = "10.1016/j.jpha.2012.09.007" }
Jančić-Stojanović, B., Rakić, T., Slavković, B., Kostić, N., Vemić, A.,& Malenović, A.. (2013). Systematical approach in evaluation of LC method for determination of raloxifene hydrochloride and its impurities employing experimental design. in Journal of Pharmaceutical Analysis Xi'an Jiaotong University., 3(1), 45-52. https://doi.org/10.1016/j.jpha.2012.09.007
Jančić-Stojanović B, Rakić T, Slavković B, Kostić N, Vemić A, Malenović A. Systematical approach in evaluation of LC method for determination of raloxifene hydrochloride and its impurities employing experimental design. in Journal of Pharmaceutical Analysis. 2013;3(1):45-52. doi:10.1016/j.jpha.2012.09.007 .
Jančić-Stojanović, Biljana, Rakić, Tijana, Slavković, B, Kostić, Nada, Vemić, Ana, Malenović, Anđelija, "Systematical approach in evaluation of LC method for determination of raloxifene hydrochloride and its impurities employing experimental design" in Journal of Pharmaceutical Analysis, 3, no. 1 (2013):45-52, https://doi.org/10.1016/j.jpha.2012.09.007 . .