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Study on development and validation of an HPLC method for determination of content and related substances of fuduositan oral solution and its stability

Pan Ying-yu

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Abstract

To establish an HPLC method for determination of the content and the related substances of Fuduositan oral solution,and then its stability was studied with this method.Method:Agilent HPLC instrument was used with a Diamonsil C_(18)scolumn(150 mm×4.6 mm,5 μm).The mobile phase was water;the wavelength of the UV absorbance detector was 210 nm;the flow rate was 1 mL·min~(-1) and the column was maintained at 40 ℃.Re- suits:The standard curve was linear in the range of 1.0-500.0 μg·mL~(-1) and the linear equation was A=3.72+ 5.66C(r=0.9999,n=7).The within-day precision and the between-day precision were both less than 1.0% (RSD).The average recovery were within 99.42%-100.2%.Conclusion:The HPLC method is specific,sensitive and reliable.The results of the stability study of Fuduositan oral solution verified that it should be stored in a cool condition and closed.

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To establish an HPLC method for determination of the content and the related substances of Fuduositan oral solution,and then its stability was studied with this method.Method:Agilent HPLC instrument was used with a Diamonsil C_(18)scolumn(150 mm×4.6 mm,5 μm).The mobile phase was water;the wavelength of the UV absorbance detector was 210 nm;the flow rate was 1 mL·min~(-1) and the column was maintained at 40 ℃.Re- suits:The standard curve was linear in the range of 1.0-500.0 μg·mL~(-1) and the linear equation was A=3.72+ 5.66C(r=0.9999,n=7).The within-day precision and the between-day precision were both less than 1.0% (RSD).The average recovery were within 99.42%-100.2%.Conclusion:The HPLC method is specific,sensitive and reliable.The results of the stability study of Fuduositan oral solution verified that it should be stored in a cool condition and closed.

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Available abstract

To establish an HPLC method for determination of the content and the related substances of Fuduositan oral solution,and then its stability was studied with this method.Method:Agilent HPLC instrument was used with a Diamonsil C_(18)scolumn(150 mm×4.6 mm,5 μm).The mobile phase was water;the wavelength of the UV absorbance detector was 210 nm;the flow rate was 1 mL·min~(-1) and the column was maintained at 40 ℃.Re- suits:The standard curve was linear in the range of 1.0-500.0 μg·mL~(-1) and the linear equation was A=3.72+ 5.66C(r=0.9999,n=7).The within-day precision and the between-day precision were both less than 1.0% (RSD).The average recovery were within 99.42%-100.2%.Conclusion:The HPLC method is specific,sensitive and reliable.The results of the stability study of Fuduositan oral solution verified that it should be stored in a cool condition and closed.

Key concepts: Chemistry, Chromatography, Absorbance, High-performance liquid chromatography, Linear range, Linear relationship, Standard curve, Content determination

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