离子色谱法测定米诺膦酸及其片剂的含量
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摘要
目的:建立离子色谱法测定米诺膦酸及其片剂中米诺膦酸的含量。方法:采用IonPac AS23阴离子交换色谱柱分离,淋洗液为3 mmol·L~(-1)草酸溶液,流速为1.0 mL·min~(-1),柱温为30℃,进样量为25μL,检测方式为电导检测器。结果:米诺膦酸在9.50～380.08μg·mL~(-1)范围内线性关系良好(r=1.000 0);片剂的平均加样回收率为99.2%(RSD为0.4%,n=9)。结论:该方法准确、灵敏、简便,可用于米诺膦酸原料药及其制剂中米诺膦酸的含量测定。
Objective: To establish an ion chromatography method to determine the content of minodronic acid in minodronic acid drug substance and tablets. Methods: The separation was performed in an IonPac AS23 anion exchange column under the elution of 3 mmol·L~(-1) oxalic acid solution. The flow rate was 1.0 mL·min~(-1), the column temperature was 30 ℃, and the injection volumn was 25 μL. The conductivity detector was used. Results: The linear range of minodronic acid fell into 9.50-380.08 μg·mL~(-1)(r=1.000 0), and the spiked average recovery of minodronic acid tablets was 99.2% with RSD as 0.4%(n=9). Conclusion: The established method is accurate, sensitive and simple. It can be used for assay of minodronic acid drug substance and tablets.
Objective: To establish an ion chromatography method to determine the content of minodronic acid in minodronic acid drug substance and tablets. Methods: The separation was performed in an IonPac AS23 anion exchange column under the elution of 3 mmol·L~(-1) oxalic acid solution. The flow rate was 1.0 mL·min~(-1), the column temperature was 30 ℃, and the injection volumn was 25 μL. The conductivity detector was used. Results: The linear range of minodronic acid fell into 9.50-380.08 μg·mL~(-1)(r=1.000 0), and the spiked average recovery of minodronic acid tablets was 99.2% with RSD as 0.4%(n=9). Conclusion: The established method is accurate, sensitive and simple. It can be used for assay of minodronic acid drug substance and tablets.
引文
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[2] 蒋晔,张晓青,徐智儒,等.唑来膦酸的电位滴定法测定[J].中国医药工业杂志,2005,36(1):37JIANG Y,ZHANG XQ,XU ZR,et al.Determination of zoledronic acid by potentiometric titration[J].Chin J Pharm,2005,36(1):37
[3] 谢赞,蒋晔,田书霞.反相离子对色谱—蒸发光散射法测定帕米膦酸钠及其有关物质[J].药物分析杂志,2006,26(12):1729XIE Z,JIANG Y,TIAN SX.RPIC-ELSD determination of pamidronate and its related substances[J].Chin J Pharm Anal,2006,26(12):1729
[4] 张立峰,刘灿仿.离子对RP-HPLC法测定利塞膦酸钠原料药及其制剂的含量[J].中国药房,2013,24(41):912ZHANG LF,LIU CF.Content determination of risedronate sodium raw material and its preparations by ion-pair RP-HPLC [J].China Pharm,2013,24(41):3912
[5] 陈军,钟新林,余彦海.离子色谱法测定膦甲酸钠注射液含量及有关物质[J].中国药学杂志,2012,47(20):1658CHEN J,ZHONG XL,YU YH.Determination of foscarnet sodium injection and its related substance by ion chromatography [J].Chin Pharm J,2012,47(20):1658
[6] 熊婧,吴建敏,岳志华,等.离子色谱法测定依替膦酸二钠及其片剂的含量及有关物质[J].药物分析杂志,2012,32(2):310XIONG J,WU JB,YUE ZH,et al.Determination of etidronate disodium and its related substances in its tablets by ion chromatography [J].Chin J Pharm Anal,2012,32(2):310
[7] 中华人民共和国药典2015年版.二部[S].2015:1402ChP 2015.Vol Ⅱ[S].2015:1402
[8] 中华人民共和国药典2015年版.二部[S].2015:536ChP 2015.Vol Ⅱ[S].2015:536
[9] 邬方宁.高效液相色谱法测定米诺膦酸片中米诺膦酸[J].现代药物与临床,2011,26(1):66WU FN.Determination of minodronic acid in minodronic acid tablets by HPLC[J].Drug Clin,2011,26(1):66
[10] 宋伟杰,周玥莹,王立强,等.高效液相色谱法测定米诺膦酸的含量及有关物质[J].中国新药杂志,2018,27(16):1932SONG WJ,ZHOU YY,WANG LQ,et al.Determination of the content and related substances of minodronic acid by HPLC[J].Chin J New Drugs,2018,27(16):1932