Study on the Determination Method for Related Substances in Bisacodyl Raw Material and Enteric-coated Tablet / 中国药房
China Pharmacy
;
(12): 2995-2997, 2016.
Artigo
em Chinês
| WPRIM
| ID: wpr-504708
ABSTRACT
OBJECTIVE:
To establish a method for the determination of related substances in bisacodyl raw material and enteric-coated tablet.METHODS:
HPLC was performed on the column of Hibar C18 with mobile phase of acetonitrile-20 mmol/L ammonium acetate (acetic acid adjust pH to 5.0)(55∶45,V/V),detection wavelength was 265 nm,flow rate was 1.0 ml/min, column temperature was 30℃,and the injection volume was 20 μl.RESULTS:
The linear range of bisacodyl was 0.25-5.0 mg/ml (r=0.999 9);the limits of detection and quantification were 19-25 ng and 61-68 ng for bisacodyl and impurity A,B,C,D and E;RSDs of precision,stability and reproducibility tests were lower than 2%;recovery was 99.50%-101.00%(RSD=0.5%,n=9).CONCLUSIONS:
The method is specific, sensitive and reproducible, and can be used for the determination of related substance in bisacodyl raw material and enteric-coated tablet.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
China Pharmacy
Ano de publicação:
2016
Tipo de documento:
Artigo
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