HPLC同时测定虎力散片剂中10个核苷和碱基类成分含量

目的: 建立同时测定虎力散片剂中7个核苷(胞苷、尿苷、腺苷、2-脱氧尿苷、鸟苷、2-脱氧鸟苷、胸苷)和3个碱基(腺嘌呤、次黄嘌呤、黄嘌呤)类成分含量的HPLC方法. 方法: 采用Waters Xselect^TM HssC₁₈ (4.6 mm×250 mm,5 μm)色谱柱,以甲醇(A)-0.1%磷酸水溶液(B)为流动相,梯度洗脱,流速0.6 mL·min^-1,柱温30 ℃,检测波长260 nm. 结果: 腺嘌呤、胞苷、次黄嘌呤、黄嘌呤、尿苷、腺苷、2-脱氧尿苷、鸟苷、2-脱氧鸟苷、胸苷质量浓度分别在9.07~181.44、5.03~100.50、 2.03~40.60、1.54~30.87、3.57~71.47、1.25~25.08、3.01~60.24、2.02~40.48、0.52~10.40、1.05~21.00 μg·mL^-1 范围内与峰面积呈良好线性关系(r≥0.9994);平均回收率(n=6)为96.2%~103.5%,RSD≤2.6%. 结论: 本试验所建立的用于同时测定虎力散片剂中核苷及碱基类成分含量的分析方法简单、重复性好、准确高,可为虎力散片剂的质量控制提供依据.

Objective: To establish an HPLC method for simultaneous determination of ten nucleoside and nucleobase components in Hulisan tablets. Methods: The assay was performed on a Waters Xselect^TM Hss C₁₈ column(4.6 mm×250 mm,5 μm);the mobile phase consisted of methanol(phase A)-0.1% orthophosphoric acid water(phase B)with gradient elution at a flow rate of 0.6 mL·min^-1;the column temperature was 30 ℃,and the detection wavelength was 260 nm. Results: The investigated compounds including adenin,cytidine,hypoxanthine,xanthine,uridine,adenosine,2-deoxyuridine,guanosin,2-deoxidation inosine and thymidine showed good linearity(r≥0.9994)in the ranges of 9.07-181.44,5.03-100.50,2.03-40.60,1.54-30.87,3.57-71.47,1.25-25.08,3.01-60.24,2.02-40.48,0.52-10.40 and 1.05-21.00 μg·mL^-1,respectively.The average recoveries(n=6)ranged 96.2%-103.5% with RSD≤2.6%. Conclusion: The HPLC method developed for simultaneous determination of nucleoside components was simple and valid. It could be used for quality evaluation and quality control of the Hulisan tablets.