Dai Shi-Ying, Qiu Shi-Ting, Wu Wei, Fu Chun-Mei
Key Laboratory of Drug Targeting and Drug Delivery System, Ministry of Education, West China School of Pharmacy, Sichuan University, No. 17, Block 3, Southern Renmin Road, Chengdu 610041, China.
J Pharm Anal. 2013 Dec;3(6):440-446. doi: 10.1016/j.jpha.2013.09.002. Epub 2013 Oct 2.
An rp-hplc method for the simultaneous determination of Ramipril (RP) and Amlodipine (AL) in tablets was developed and validated by Chinese Pharmacopoeia 2010. The linearity of the proposed method was investigated in the range of 0.01-0.25 mg/mL (=0.9998) for RP and 0.014-0.36 mg/mL (=0.9997) for AL. The limits of detection (LOD) were 0.06 μg/mL and 0.02 μg/mL for RP and AL, and the limits of quantitation (LOQ) were 0.2 μg/mL and 0.07 μg/mL, respectively. Some major impurities and degradation products did not disturb the detection of RP and AL and the assay can thus be considered stability-indicating.
建立了一种采用反相高效液相色谱法同时测定片剂中雷米普利（RP）和氨氯地平（AL）的方法，并按照《中国药典》2010年版进行了方法验证。该方法对RP的线性研究范围为0.01 - 0.25 mg/mL（=0.9998），对AL的线性研究范围为0.014 - 0.36 mg/mL（=0.9997）。RP和AL的检测限分别为0.06 μg/mL和0.02 μg/mL，定量限分别为0.2 μg/mL和0.07 μg/mL。一些主要杂质和降解产物不干扰RP和AL的检测，因此该测定法可视为稳定性指示方法。
