高效液相色谱法测定可溶微针贴片中维生素C的含量
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摘要
目的建立高效液相色谱法测定可溶微针贴片中维生素C的含量。方法采用高效液相色谱法,选择Luna C18100A色谱柱(250 mm×4. 6 mm,5μm);流动相为乙腈-水-冰醋酸(10∶89∶1);流速为0. 6 ml/min;柱温为30℃;检测波长为254 nm。考察方法的专属性、线性、精密度、加样回收率、重复性及稳定性。结果维生素C浓度在2. 32-116μg/ml内与HPLC峰面积呈良好的线性关系(Y=88 754X-188 466,R2=0. 999 0),日内精密度的平均RSD值为0. 74%,日间精密度的平均RSD值为0. 56%,平均加样回收率为105. 86%,方法的专属性和重复性良好,供试品溶液24 h内较稳定。结论本研究所建立的高效液相色谱法测定可溶微针贴片中维生素C的含量简便、准确。
Objective To establish a HPLC method for determining the content of vitamin C in dissolving microneedles array. Methods High performance liquid chromatography was used by Luna C18100 A column( 250 mm × 4. 6 mm,5 μm). Acetonitrile-water-glacial acetic acid( 10 ∶ 89 ∶ 1,V ∶ V ∶ V) was used as the mobile phase. The flow rate was 0. 6 ml/min. The column temperature was 30 ℃ and the detection wavelength was 254 nm. The specificity,linearity,precision,recovery,repeatability and stability of the method were investigated. Results The calibration curve of vitamin C showed good linear relation in the range of 2. 32-116 μg/ml( Y = 88 754 X-188 466,R2= 0. 999 0). The average RSD of intraday precision was 0. 74%,and the average RSD of interday precision was 0. 56%. The average recovery was 105. 86%. The method showed good specificity and repeatability,and the solution was stable in 24 h. Conclusion The established HPLC method for determining the content of vitamin C in dissolving microneedles array is simple and accurate.
Objective To establish a HPLC method for determining the content of vitamin C in dissolving microneedles array. Methods High performance liquid chromatography was used by Luna C18100 A column( 250 mm × 4. 6 mm,5 μm). Acetonitrile-water-glacial acetic acid( 10 ∶ 89 ∶ 1,V ∶ V ∶ V) was used as the mobile phase. The flow rate was 0. 6 ml/min. The column temperature was 30 ℃ and the detection wavelength was 254 nm. The specificity,linearity,precision,recovery,repeatability and stability of the method were investigated. Results The calibration curve of vitamin C showed good linear relation in the range of 2. 32-116 μg/ml( Y = 88 754 X-188 466,R2= 0. 999 0). The average RSD of intraday precision was 0. 74%,and the average RSD of interday precision was 0. 56%. The average recovery was 105. 86%. The method showed good specificity and repeatability,and the solution was stable in 24 h. Conclusion The established HPLC method for determining the content of vitamin C in dissolving microneedles array is simple and accurate.
引文
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[2]王清清,马涛,李见春,等.应用于大分子药物经皮释药的可溶微针贴片制备[J].蚌埠医学院学报,2016,41(4):523-527.
[3] Matsuo K,Yokota Y,Zhai Y,et al. A low-invasive and effective transcutaneous immunization system using a novel dissolving microneedle array for soluble and particulate antigens[J]. J Control Release,2012,161(1):10-17.
[4] Arya JM,Dewitt K,Scott Garrard M,et al. Rabies vaccination in dogs using a dissolving microneedle patch[J]. J Control Release,2016,239(10):19-26.
[5] Wang Q,Yao G,Dong P,et al. Investigation on fabrication process of dissolving microneedle arrays to improve effective needle drug distribution[J]. Eur J Pharm Sci,2015,66(23):148-156.
[6]刘彬,赵惠新.维生素C含量测定方法综述及其比较[J].课程教育研究,2018,(42):178-179.
[7]胡霞,陈明龙,杨伟汉,等. HPLC测定可溶微针贴片中熊果苷的含量[J].山西医科大学学报,2018,49(5):498-501.
[8]国家药典委员会.中国药典2015年版:二部[S].北京:中国医药科技出版社,2015:1237-1238.
[9]贺澎,王文丽.维生素C片3种含量测定方法的比较[J].中国药品标准,2018,19(2):112-114.
[10]王奇年. HPLC法测定维生素C注射液中维生素C的含量[J].北方药学,2015,12(9):9-10.