Analytical method development of nifedipine and its degradants binary mixture using high performance liquid chromatography through a quality by design approach

International Conference on Advanced Materials for Better Future 2017

Choiri, S.^1,2 ; Ainurofiq, A.^2 ; Ratri, R.^3 ; Zulmi, M.U.^3

Department of Pharmacy, Sebelas Maret University, Ir. Sutami 36 A, Surakarta

57126, Indonesia^1

Faculty of Pharmacy, Gadjah Mada University, Sekip Utara, Yogyakarta

55281, Indonesia^2

Department of Pharmaceutical Science and Technology, Setiabudi University, Surakarta

57127, Indonesia^3

关键词: Analytical conditions;    Analytical method;    Analytical method development;    Cross validation;    Full factorial design;    Mobile-phase composition;    Quality by designs;    Theoretical plates;   

Others  :  https://iopscience.iop.org/article/10.1088/1757-899X/333/1/012064/pdf
DOI  :  10.1088/1757-899X/333/1/012064

来源: IOP

【 摘 要 】

Nifedipin (NIF) is a photo-labile drug that easily degrades when it exposures a sunlight. This research aimed to develop of an analytical method using a high-performance liquid chromatography and implemented a quality by design approach to obtain effective, efficient, and validated analytical methods of NIF and its degradants. A 22full factorial design approach with a curvature as a center point was applied to optimize of the analytical condition of NIF and its degradants. Mobile phase composition (MPC) and flow rate (FR) as factors determined on the system suitability parameters. The selected condition was validated by cross-validation using a leave one out technique. Alteration of MPC affected on time retention significantly. Furthermore, an increase of FR reduced the tailing factor. In addition, the interaction of both factors affected on an increase of the theoretical plates and resolution of NIF and its degradants. The selected analytical condition of NIF and its degradants has been validated at range 1 - 16 μg/mL that had good linearity, precision, accuration and efficient due to an analysis time within 10 min.