Ashour Safwan, Omar Soulafa
Analytical Biochemistry Laboratory, Department of Chemistry, Faculty of Science, University of Aleppo, Aleppo, Syria.
Int J Biomed Sci. 2011 Dec;7(4):283-8.
A reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of rosuvastatin calcium in pharmaceutical dosage forms. The determination was performed on a Nucleodur column C8 (250 × 4.6 mm i.d., 5 μm particle size); the mobile phase consisted of a mixture of 0.1M formic acid and methanol (25:75, v/v), pumped at a flow rate 1.0 mL min(-1). The photodiode array detector was operated at 280 nm. The retention times for rosuvastatin and fluvastatin, which was used as internal standard, were 3.98 and 7.78 min, respectively. Linearity range (r (2) better than 0.999, n=6) was 3.0-1602.0 μg mL(-1) with limit of detection value of 0.12 μg mL(-1). The precision of the method was demonstrated using intra- and inter-day assay RSD% values which were less than 2.40%, while the recovery was 99.86-102.86%. The method was applied in the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.
建立并验证了一种反相高效液相色谱法，用于测定药物剂型中的瑞舒伐他汀钙。测定在Nucleodur C8柱（250×4.6 mm内径，5μm粒径）上进行；流动相由0.1M甲酸和甲醇的混合物（25:75，v/v）组成，以1.0 mL min(-1)的流速泵送。光电二极管阵列检测器在280 nm波长下运行。瑞舒伐他汀和用作内标的氟伐他汀的保留时间分别为3.98和7.78分钟。线性范围（r(2)优于0.999，n = 6）为3.0 - 1602.0 μg mL(-1)，检测限为0.12 μg mL(-1)。该方法的精密度通过日内和日间测定的RSD%值证明小于2.40%，回收率为99.86 - 102.86%。该方法应用于市售片剂的质量控制和含量均匀度测试，证明适用于快速可靠的质量控制。
