CAJ | 학술논문

目的：建立加校正因子的主成分自身对照法测定盐酸去氧肾上腺素中杂质 C 的含量。方法采用 C18柱（4.6 mm ×250 mm，5μm），以乙腈：0.325%磺酸钠（用磷酸调节 pH 值为2.8）（10：90）为流动相，梯度洗脱，流速为1.5 mL·min -1，柱温为45℃，检测波长为215 nm，进样量为20μL。测定杂质 C 相对于盐酸去氧肾上腺素的相对出峰时间及校正因子，并计算其含量。结果杂质 C 在0.0651~1.6269μg·mL -1，盐酸去氧肾上腺素在0.0647~1.6184μg·mL -1浓度范围内，峰面积与浓度呈良好的线性关系；杂质 C 相对于盐酸去氧肾上腺素的相对保留时间为1.3，校正因子为0.50。结论本方法专属性强，结果准确可靠，无需提供杂质对照品，能够准确测定盐酸去氧肾上腺素中杂质 C 的含量。
목적：건립가교정인자적주성분자신대조법측정염산거양신상선소중잡질 C 적함량。방법채용 C18주（4.6 mm ×250 mm，5μm），이을정：0.325%광산납（용린산조절 pH 치위2.8）（10：90）위류동상，제도세탈，류속위1.5 mL·min -1，주온위45℃，검측파장위215 nm，진양량위20μL。측정잡질 C 상대우염산거양신상선소적상대출봉시간급교정인자，병계산기함량。결과잡질 C 재0.0651~1.6269μg·mL -1，염산거양신상선소재0.0647~1.6184μg·mL -1농도범위내，봉면적여농도정량호적선성관계；잡질 C 상대우염산거양신상선소적상대보류시간위1.3，교정인자위0.50。결론본방법전속성강，결과준학가고，무수제공잡질대조품，능구준학측정염산거양신상선소중잡질 C 적함량。
Objective To establish a method for the determination of impurity C in phenylephrine hydrochloride by main constituent own control method with correction factor. Methods The assay was carried out on a C18 column(4. 6 mm × 250 mm,5 μm)with the mobile phase of acetonitrile - 0. 325% sodium sulfonate solution(with phosphoric acid to adjust pH value of 2. 8)(10:90)at a flow rate of 1. 5 mL·min - 1. The column temperature,the detection wave length and the in-jection volume were set at 45 ℃,215 nm,and 20 μL. The relative retention time and the correction factor between impurity C and phenylephrine hydrochloride were determined. Results The linear ranges of impurity C and phenylephrine hydro-chloride were 0. 065 1 ~ 1. 626 9 μg·mL - 1 ,0. 064 7 ~ 1. 618 4 μg·mL - 1 ,respectively. The relative retention time be-tween impurity C and phenylephrine hydrochloride was 1. 3,the correction factor between impurity C and phenylephrine hydrochloride was 0. 50. Conclusion This method was simple,accurate and reliable to determine impurity C in phenyleph-rine hydrochloride. without standard substances.