RP-HPLC法检测左旋甲状腺素钠片剂含量及溶出度

【目的】建立左旋甲状腺素钠反相高效液相色谱(RP-HPLC)测定法, 检测和比较2 种进口的左旋甲状腺素钠片 剂的含量和溶出度。【方法】用RP-HPLC 法测定2 种片剂中左旋甲状腺素钠含量, 依照美国药典第23 版溶出度测定Ⅱ 法测 定左旋甲状腺素钠片剂溶出度。色谱条件:Hy persil BDS C18 柱;流动相:0.85 (mL/ 100m L)磷酸溶液-甲醇(40∶60);检测波 长:225 nm ;流速:1.5 mL/ min 。【结果】2 种片剂含量占标示量百分率分别为107.74%和99.72%。两种片剂溶出50 %和 63.2%所需的时间及m 值均有极显著性差异(P <...

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Published inZhongshan da xue xue bao. Zhongshan daxue xuebao yixue kexue ban = Journal of Sun Yat-sen University. Yi xue ke xue ban Vol. 22
Main Authors 伍杰雄, 任 斌, 唐 蕾
Format Journal Article
LanguageChinese
Published Editorial Office of Journal of Sun Yat-sen University 01.01.2001
Online AccessGet full text
ISSN1672-3554
DOI10.3321/j.issn:1672-3554.2001.03.023

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Abstract 【目的】建立左旋甲状腺素钠反相高效液相色谱(RP-HPLC)测定法, 检测和比较2 种进口的左旋甲状腺素钠片 剂的含量和溶出度。【方法】用RP-HPLC 法测定2 种片剂中左旋甲状腺素钠含量, 依照美国药典第23 版溶出度测定Ⅱ 法测 定左旋甲状腺素钠片剂溶出度。色谱条件:Hy persil BDS C18 柱;流动相:0.85 (mL/ 100m L)磷酸溶液-甲醇(40∶60);检测波 长:225 nm ;流速:1.5 mL/ min 。【结果】2 种片剂含量占标示量百分率分别为107.74%和99.72%。两种片剂溶出50 %和 63.2%所需的时间及m 值均有极显著性差异(P <0.01)。【结论】两种进口左旋甲状腺素钠片剂的含量无差异, 但溶出度存 在显著性差异。
AbstractList 【目的】建立左旋甲状腺素钠反相高效液相色谱(RP-HPLC)测定法, 检测和比较2 种进口的左旋甲状腺素钠片 剂的含量和溶出度。【方法】用RP-HPLC 法测定2 种片剂中左旋甲状腺素钠含量, 依照美国药典第23 版溶出度测定Ⅱ 法测 定左旋甲状腺素钠片剂溶出度。色谱条件:Hy persil BDS C18 柱;流动相:0.85 (mL/ 100m L)磷酸溶液-甲醇(40∶60);检测波 长:225 nm ;流速:1.5 mL/ min 。【结果】2 种片剂含量占标示量百分率分别为107.74%和99.72%。两种片剂溶出50 %和 63.2%所需的时间及m 值均有极显著性差异(P <0.01)。【结论】两种进口左旋甲状腺素钠片剂的含量无差异, 但溶出度存 在显著性差异。
Author 伍杰雄
任 斌
唐 蕾
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PublicationTitle Zhongshan da xue xue bao. Zhongshan daxue xuebao yixue kexue ban = Journal of Sun Yat-sen University. Yi xue ke xue ban
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Snippet 【目的】建立左旋甲状腺素钠反相高效液相色谱(RP-HPLC)测定法, 检测和比较2 种进口的左旋甲状腺素钠片 剂的含量和溶出度。【方法】用RP-HPLC 法测定2 种片剂中左旋甲状腺素钠含...
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Title RP-HPLC法检测左旋甲状腺素钠片剂含量及溶出度
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