盐酸克仑特罗片剂中克仑特罗及其杂质含量的HPLC测定
DETERMINATION OF CLENBUTEROL HYDROCHLORIDE AND IMPURITIES IN TABLETS BY HPLC
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摘要: 建立了测定盐酸克仑特罗片剂含量的高效液相色谱法.选用Agilent Eclipse XDB-C8柱 (4.6 mm×250 mm,5 μm),流动相为甲醇-水(40∶60,含20 mmol·L-1磷酸二氢钾,以磷酸调至pH 4.0),流速为1.0 mL·min-1,检测波长240 nm,线性范围为0.50-50.0 mg·L-1(r=0999 9),检出限为0.5 ng,回收率在98.5-102.0%之间,RSD为2.06%-3.07%(n=5).Abstract: In the HPLC determination of clenbuterol hydrochloride in its tablets,agilent eclipse XDB-C8 column (4.6 mm×250 mm,5 μm) and mobile phase of methanol-water (40∶60) mixture,containing 20 mmol·L-1 KH2PO4 adjusted to pH 4.0 with H3PO4 (2+998) were used.The flow-rate of the sample solution of 1.0 mL per min,and the UV detection at 240 nm were taken.Range of linearity of the method was found in the range of 050-50.0 mg·L-1 of clenbuterol (r=0.999 9),with a detection limit of 0.5 ng.In the analysis of samples of clenbuterol hydrochloride tablets of known contents,RSD′s (n=5) obtained were in the range from 2.06% to 307%,and recoveries found by the standard addition method were in the range of 98.5%-102.0%.
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