愈酚喷托异丙嗪颗粒含量测定方法的优化
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摘要
目的:对愈酚喷托异丙嗪颗粒含量测定方法进行优化,建立HPLC法测定颗粒中愈创木酚磺酸钾、枸橼酸喷托维林、盐酸异丙嗪的含量。方法:色谱柱为C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-磷酸盐缓冲液(取磷酸二氢钾2.72 g和四丁基硫酸氢铵3.4 g,加水800 ml使溶解,用1 mol·L~1磷酸氢二钾溶液调节pH至3.5,加水稀释至1 000 ml)(15∶85),流速为1.0 ml·min~(-1),检测波长为218 nm,柱温:35℃,进样量:20μl。结果:愈创木酚磺酸钾在0.14～1.10 mg·ml~(-1)的浓度范围内线性关系良好(r=1.000 0);平均回收率为100.3%,RSD为0.6%(n=9);盐酸异丙嗪在5.537～44.297μg·ml~(-1)的浓度范围内线性关系良好(r=1.000 0);平均回收率为99.8%,RSD为0.6%(n=9);枸橼酸喷托维林在11.074～88.593μg·ml~(-1)的浓度范围内与峰面积线性关系良好(r=1.000 0);平均回收率为100.0%,RSD为0.4%(n=9)。结论:优化后的方法更准确、重复性好,可提高愈酚喷托异丙嗪颗粒的质量标准。
Objective: To optimize the content determination of promethazine hydrochloride,pentoxyverine citrate and guaiacol sulfonic acid potassium in sulfogaiacol,pentoxyverine and promethazine granule by HPLC. Methods: The HPLC method was performed on a Hibar C_(18) column (250 mm×4.6 mm,5 μm). The column temperature was 35℃ and the flow rate was 1.0 ml·min~(-1). The mobile phase was a mixture of buffer solution-acetonitrile (85 ∶15),and the buffer solution contained 2.72 g dipotassium hydrogenphosphate and 3.4 g tetrabutylammonium hydrogen sulfate in 800 ml water and the pH value was adjusted to 3.5 by 1 mol·L~1 dipotassium hydrogenphosphate solution and diluted to 1 000 ml by water. The detection wavelength was 218 nm,and the sample size was 20 μl. Results:The linear range of guaiacol sulfonic acid potassium was 0.14-1.10 mg·ml~(-1) (r= 1.000 0),and the average recovery was 100.3% with the RSD of 0.6% (n = 9). The linear range of promethazine hydrochloride was 5.537-44.297 μg·ml~(-1) (r= 1.000 0),and the average recovery was 99.8% with the RSD of 0.6% (n = 9). The linear range of pentoxyverine citrate was 11.074-88.593 μg · ml~(-1) (r =1.000 0),and the average recovery was 100.0% with the RSD of 0.4% (n = 9). Conclusion: The optimized method is more accurate and reproducible,and can improve the quality standard of sulfogaiacol,pentoxyverine and promethazine granule.
Objective: To optimize the content determination of promethazine hydrochloride,pentoxyverine citrate and guaiacol sulfonic acid potassium in sulfogaiacol,pentoxyverine and promethazine granule by HPLC. Methods: The HPLC method was performed on a Hibar C_(18) column (250 mm×4.6 mm,5 μm). The column temperature was 35℃ and the flow rate was 1.0 ml·min~(-1). The mobile phase was a mixture of buffer solution-acetonitrile (85 ∶15),and the buffer solution contained 2.72 g dipotassium hydrogenphosphate and 3.4 g tetrabutylammonium hydrogen sulfate in 800 ml water and the pH value was adjusted to 3.5 by 1 mol·L~1 dipotassium hydrogenphosphate solution and diluted to 1 000 ml by water. The detection wavelength was 218 nm,and the sample size was 20 μl. Results:The linear range of guaiacol sulfonic acid potassium was 0.14-1.10 mg·ml~(-1) (r= 1.000 0),and the average recovery was 100.3% with the RSD of 0.6% (n = 9). The linear range of promethazine hydrochloride was 5.537-44.297 μg·ml~(-1) (r= 1.000 0),and the average recovery was 99.8% with the RSD of 0.6% (n = 9). The linear range of pentoxyverine citrate was 11.074-88.593 μg · ml~(-1) (r =1.000 0),and the average recovery was 100.0% with the RSD of 0.4% (n = 9). Conclusion: The optimized method is more accurate and reproducible,and can improve the quality standard of sulfogaiacol,pentoxyverine and promethazine granule.
引文
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4姜云平,曾仁杰,张勤,等.高效液相色谱法测定盐酸异丙嗪片的含量[J].西南国防医药,2004,14(1):29-31
5李霞,柳小秦,王红英,等.复方枸橼酸喷托维林颗粒中枸橼酸喷托维林的含量测定[J].西北药学杂志,2015,30(2):145-146
6童龙标.高效液相色谱法测定枸橼酸喷托维林片含量[J].医药导报,2011,30(3):375-376
7蔡涛.HPLC法同时测定氨酚异丙嗪注射液中对乙酰氨基酚与盐酸异丙嗪的含量[J].中国药品标准,2012,13(6):441-442,461
2赵明.高效液相色谱法测定复方愈创木酚磺酸钾口服溶液中2组分的含量[J].中国医院药学杂志,2008,28(1):77-78
3郭平,史奕.HPLC法测定愈创木酚磺酸钾的含量[J].江苏药学与临床研究,2000,8(2):29-30
4姜云平,曾仁杰,张勤,等.高效液相色谱法测定盐酸异丙嗪片的含量[J].西南国防医药,2004,14(1):29-31
5李霞,柳小秦,王红英,等.复方枸橼酸喷托维林颗粒中枸橼酸喷托维林的含量测定[J].西北药学杂志,2015,30(2):145-146
6童龙标.高效液相色谱法测定枸橼酸喷托维林片含量[J].医药导报,2011,30(3):375-376
7蔡涛.HPLC法同时测定氨酚异丙嗪注射液中对乙酰氨基酚与盐酸异丙嗪的含量[J].中国药品标准,2012,13(6):441-442,461