نوع مقاله : مقاله علمی پژوهشی
نویسنده
دانشکده علوم پایه، گروه شیمی، دانشگاه یاسوج، یاسوج، ایران
چکیده
کلیدواژهها
موضوعات
عنوان مقاله [English]
نویسنده [English]
This research employed a method using high-performance liquid chromatography with a visible-ultraviolet detector (HPLC-UV-Vis) to measure Benidipine Hydrochloride in pharmaceutical, human urine, and serum samples. The proposed method was validated based on the guidelines of the International Conference on Harmonisation (ICH) after optimizing various chromatography conditions and other experimental parameters.
Optimal results were obtained using an ACE 5µm C18 column (150 mm × 6.4 mm; 0.5µm) at 45 °C. The mobile phase consisted of acetonitrile: buffer (40 mM ammonium acetate) in a ratio of 75:25 v/v% adjusted to a pH of 6.75 at a flow rate of 0.1 mL/min. A wavelength of 238 nm was selected. The method was fully validated, and the validation parameters included a linear range of 0.15-25.00 mg/L and a correlation coefficient of 0.999 for all samples. The detection limits of Benidipine Hydrochloride were found to be 0.46, 1.20, and 8.30 µg/L in acetonitrile, serum, and human urine, respectively. The quantification limits in acetonitrile, serum, and human urine were 1.50, 3.80, and 27.00 µg/L, respectively. The precision, between-day and within-day, represented by the relative standard deviation (%RSD), was found to be 0.13% and 0.27% respectively in the buffer/acetonitrile solution. The average relative recovery values ranged between 97.00% and 105.00%. Thus, the proposed method is rapid and precise, and it can be successfully employed in pharmacokinetic studies and routine clinical performance.
کلیدواژهها [English]
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