RP-HPLC法测定雾化温度对吸入用布地奈德混悬液稳定性的影响 |
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引用本文: | 周清,冯钰凤,韩海涛,刘妮,胡杰英,杨峰,吴璐璐,董环,何薇,曹燕妃,郑则广.RP-HPLC法测定雾化温度对吸入用布地奈德混悬液稳定性的影响[J].中国医学装备,2020(1):160-162. |
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作者姓名: | 周清 冯钰凤 韩海涛 刘妮 胡杰英 杨峰 吴璐璐 董环 何薇 曹燕妃 郑则广 |
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作者单位: | 广东药科大学药学院;广州昊熹医疗科技有限公司;广州医科大学附属第一医院呼吸内科广州呼吸健康研究院呼吸疾病国家重点实验室 |
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摘 要: | 目的:建立雾化温度对吸入用布地奈德混悬液稳定性影响的测定方法。方法:采用反相高效液相色谱(RP-HPLC)法,以Gemini C18色谱柱(4.6 mm×250 mm,5 m)为分离柱,以甲醇+水82∶18(V/V)体积比为流动相,流速为1.0 ml/min,检测波长为244 nm,柱温约为25℃,测定雾化温度对吸入用布地奈德混悬液稳定性的影响。结果:布地奈德的保留时间约为6 min,布地奈德与其他组峰的分离度>1.5;方法精密度试验RSD为0.46%;供试品溶液在24 h内稳定。布地奈德在浓度0.01~0.15 mg/ml范围内与峰面积呈现良好的线性关系,回归方程为:A=5×107 c+20336(r=0.9999)。不同批次样品测量平均回收率为96.35%(RSD=1.01%,n=3)。超声雾化仪药杯底部中心点最高温度≤46℃,供试品溶液在80℃以内稳定。结论:RP-HPLC法测定吸入用布地奈德混悬液的含量,其精密度好、准确度高,布地奈德在雾化过程中能够保持稳定,不受温度变化的影响。
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关 键 词: | 反相高效液相色谱(RP-HPLC) 布地奈德 混悬液 稳定性 超声雾化 |
The influence of atomization temperature on the stability of inhaled Budesonide suspension by RP-HPLC determination |
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Abstract: | Objective:To establish a determination method for the influence of atomization temperature on the stability of inhaled Budesonide suspension.Methods:A reversed-phase high performance liquid chromatography(RP-HPLC)method was adopted.The Gemini C 18(4.6 mm×250 mm,5m)was used as separation column.And the mobile phase was a mixture of CH3OH-H2O(the volume ratio was 82:18,V/V),and the flow rate was 1.0 ml/min,and UV detection wavelength was 244 nm.And the temperature of column was 25℃.The influence of atomization temperature on the stability of inhaled Budesonide suspension was determined.Results:The retention time of Budesonide standard substance was 6 min,and the separating degree between Budesonide and other components was greater than 1.5.The relative standard deviation(RSD)of precision test was 0.46%,and the sample solution was stable within 24h.And there was a well linear relation between the concentration range of Budesonide(0.01~0.15 mg/mL)and peak area,and the linear equation was:A=5×107c+20336(r=0.9999).The average recovery of Budesonide among various batches was 96.35%(RSD=1.01%,n=3).The highest temperature at the center point of the bottom of medicine cup of ultrasonic atomizer did not exceed 46℃,and the sample solution was stable within 80℃.Conclusion:The RP-HPLC method has better precision and higher accuracy in determining inhaled Budesonide suspension.And Budesonide can remain stable during atomization and does not be affected by temperature changes in this method. |
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Keywords: | Reversed-phase high performance liquid chromatography(RP-HPLC) Budesonide Suspension Stability Ultrasonic atomization |
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