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2008•Qilu Pharmaceutical AffairsRequires access

Determination of content and related substances of Gliclazide Tablets

Wang Xiao-Lin

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Abstract

OBJECTIVE To establish methods for determination of content and related substances in Gliclazide Tablets.METHODS Determination of content in Gliclazide Tablets by UV and determination of related substances in Gliclazide tablets by HPLC.RESULTS The linear range of Gliclazide measured by UV was 5～30μg·mL-1(r=0.9999),day-time and with-day time precision RSD was 0.67% and 1.23%,respectively.The recovery rate was 98.75%(RSD=0.46%);The linear range of Gliclazide measured by HPLC was 50～350μg·mL-1(r=0.9997),day-time and with-day time precision RSD was 0.55% and 1.86%,respectively,with detection limit of 0.25ng·mL-1,the impurity and principal agents can be separated well.CONCLUSION This method was available for determination of content and related substances in Gliclazide Tablets.

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OBJECTIVE To establish methods for determination of content and related substances in Gliclazide Tablets.METHODS Determination of content in Gliclazide Tablets by UV and determination of related substances in Gliclazide tablets by HPLC.RESULTS The linear range of Gliclazide measured by UV was 5～30μg·mL-1(r=0.9999),day-time and with-day time precision RSD was 0.67% and 1.23%,respectively.The recovery rate was 98.75%(RSD=0.46%);The linear range of Gliclazide measured by HPLC was 50～350μg·mL-1(r=0.9997),day-time and with-day time precision RSD was 0.55% and 1.86%,respectively,with detection limit of 0.25ng·mL-1,the impurity and principal agents can be separated well.CONCLUSION This method was available for determination of content and related substances in Gliclazide Tablets.

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Available abstract

OBJECTIVE To establish methods for determination of content and related substances in Gliclazide Tablets.METHODS Determination of content in Gliclazide Tablets by UV and determination of related substances in Gliclazide tablets by HPLC.RESULTS The linear range of Gliclazide measured by UV was 5～30μg·mL-1(r=0.9999),day-time and with-day time precision RSD was 0.67% and 1.23%,respectively.The recovery rate was 98.75%(RSD=0.46%);The linear range of Gliclazide measured by HPLC was 50～350μg·mL-1(r=0.9997),day-time and with-day time precision RSD was 0.55% and 1.86%,respectively,with detection limit of 0.25ng·mL-1,the impurity and principal agents can be separated well.CONCLUSION This method was available for determination of content and related substances in Gliclazide Tablets.

Key concepts: Gliclazide, Chromatography, Chemistry, High-performance liquid chromatography, Linear range, Linear relationship, Content determination, Detection limit

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