中国兽药杂志
中國獸藥雜誌
중국수약잡지
CHINESE JOURNAL OF VETERINARY DRUG
2015年
2期
35-39
,共5页
包洁华%张金霞%郭强功%张萍
包潔華%張金霞%郭彊功%張萍
포길화%장금하%곽강공%장평
高效液相色谱法%酒石酸泰乐菌素%梯度洗脱%有关物质
高效液相色譜法%酒石痠泰樂菌素%梯度洗脫%有關物質
고효액상색보법%주석산태악균소%제도세탈%유관물질
HP LC%tylosin tartrate%gradient elution%relevance substance
依据欧洲药典讨论稿中酒石酸泰乐菌素有关物质的检测方法,在280 nm波长处,以pH 5.5的磷酸盐缓冲溶液-乙腈-水(10∶27.5∶62.5,V/V)为A流动相,以pH 5.5的磷酸盐缓冲溶液-水-乙腈(10∶40∶50,V/V)为B流动相进行梯度洗脱,并对专属性、准确度、精密度、检测限和定量限、线性和范围、耐用性、及溶液稳定性进行考察。结果显示,杂质A、N、O、R、S峰峰面积与其对应浓度呈线性关系,其相关系数r均大于0.999,各项考察指标均符合要求。结果证明该分析方法能科学、合理的分析、控制酒石酸泰乐菌素有关物质,可以持续、准确地反映酒石酸泰乐菌素的特性。
依據歐洲藥典討論稿中酒石痠泰樂菌素有關物質的檢測方法,在280 nm波長處,以pH 5.5的燐痠鹽緩遲溶液-乙腈-水(10∶27.5∶62.5,V/V)為A流動相,以pH 5.5的燐痠鹽緩遲溶液-水-乙腈(10∶40∶50,V/V)為B流動相進行梯度洗脫,併對專屬性、準確度、精密度、檢測限和定量限、線性和範圍、耐用性、及溶液穩定性進行攷察。結果顯示,雜質A、N、O、R、S峰峰麵積與其對應濃度呈線性關繫,其相關繫數r均大于0.999,各項攷察指標均符閤要求。結果證明該分析方法能科學、閤理的分析、控製酒石痠泰樂菌素有關物質,可以持續、準確地反映酒石痠泰樂菌素的特性。
의거구주약전토론고중주석산태악균소유관물질적검측방법,재280 nm파장처,이pH 5.5적린산염완충용액-을정-수(10∶27.5∶62.5,V/V)위A류동상,이pH 5.5적린산염완충용액-수-을정(10∶40∶50,V/V)위B류동상진행제도세탈,병대전속성、준학도、정밀도、검측한화정량한、선성화범위、내용성、급용액은정성진행고찰。결과현시,잡질A、N、O、R、S봉봉면적여기대응농도정선성관계,기상관계수r균대우0.999,각항고찰지표균부합요구。결과증명해분석방법능과학、합리적분석、공제주석산태악균소유관물질,가이지속、준학지반영주석산태악균소적특성。
The determination method of tylosin tartrate related substances from EP discussion draft, At the wavelength of 280 nm, pH 5. 5 phosphate buffer solution-acetonitrile-water ( 10 ∶ 27. 5 ∶ 62. 5, V/V ) as the mobile phase A, pH 5.5 phosphate buffer solution-water-acetonitrile (10 ∶ 40 ∶ 50, V/V) as the mobile phase B gradient elution, and the specificity,accuracy, precision, limit of detection and limit of quantification, linearity and range, durability,and solution stability was investigated. The results showed that the impurity A, N, O, R, S peak area and the corresponding concentration showed a linear relationship, the correlation coefficient r was greater than 0.999, the indicators are in line with inspection requirements. It was demonstrated that the method can scientific, reasonable analysis, control of tylosin tartrate related substances, It can be sustained, accurately reflect the characteristics of tylosin tartrate.