口腔速溶膜剂中他达拉非的反相高效液相色谱测定

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Abstract ObjectiveTo establish ananalytical method of reverse phase high performance liquid chromatography (RPHPLC)to analyze the Tadalafil(TDF)content in Orodispersible Films(ODFs).MethodsTDF-loaded ODFs with a loading capacity up to 20 mg TDF in an area of 2 cm×3 cm were prepared using a solvent casting method.The chromatographic column was Cosmosil 5 C18-MS-Ⅱ (4.6×250 mm,5 μm)and mobile phase of acetonitrile-0.1%Trifluoroacetic Acid (44:56)were used,the detection wavelength was set at 285 nm,the flow rate was 1.0 ml/min,the column temperature was maintained at 40℃ and the injection volume was 20 μl.The drug content in TDF-loaded ODFs was analyzed.ResultsThe TDF concentration range with good linear relationship was 0.8-40 μg/ml,R2=0.9998.The RSD of intra-day was in the range of 0.002%-0.968%,RSD of inter-day was in the range of 1.22%-1.83%.Mean result of recovery rate was 99.22%.The limit of quantitation(LOQ)was 0.902 ng and the limit of detection(LOD)was 0.271 ng.The drug content of TDF-loaded ODFs was 96.43%.ConclusionThe RP-HPLC method of TDF showed high specific,good precision,recovery rate and stability.This method is suitable for thedetermination of drug content of TDF-loaded ODFs.

Key words： RP-HPLC Tadalafil Orodispersible films Polyvinyl alcohol Content determination

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	ZHAO Zong-liang
	GAO Ying
	CAO Qing-ri

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ZHAO Zong-liang,GAO Ying,CAO Qing-ri. Reverse phase high performanceliquid chromatography analysis of Tadalafil in Orodispersible Films[J]. 中国当代医药, 2017, 24(34): 8-11.

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http://dangdaiyiyao.com/EN/ OR http://dangdaiyiyao.com/EN/Y2017/V24/I34/8

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