RP-HPLC法测定曲安奈德氯霉素溶液的含量及有关物质

目的:建立高效液相色谱法测定曲安奈德氯霉素溶液中3种成分氯霉素、盐酸萘甲唑林和醋酸曲安奈德及有关物质(曲安奈德、氯霉素二醇物和对硝基苯甲醛)的含量。方法:用Dionex C18(250 mm×4.6 mm,5μm)色谱柱;流动相为0.01 mol·L-1庚烷磺酸钠溶液(取磷酸二氢钾6.8g,用0.01 mol·L-1庚烷磺酸钠溶液并稀释至1000 mL,再加三乙胺5 mL,混匀,用磷酸调节pH至2.5)(A)-甲醇(B),梯度洗脱0 min(66%A)→20 min(66%A)→30 min(35%A)→49 min(35%A)→50min(66%A)→60 min(66%A)];流速为1.0 mL·min-1;检测波长:0～20 min为277 nm,20～60 min为230 nm。结果:氯霉素、盐酸萘甲唑林、醋酸曲安奈德的线性范围分别为0.375～3.000 mg·mL-1(r=0.9990)、0.0127～0.1016 mg·mL-1(r=0.9989)和0.0262～0.2096 mg·mL-1(r=0.9992)。结论:本文建立的高效液相法结果准确可靠,专属性好,可作为曲安奈德氯霉素溶液含量和有关物质的控制方法。

RP-HPLC determination for the content and related substances of triamcinolone acetonide acetate and chloramphenicol solution

Objective:To establish an RP-HPLC method for determination of the content and related substances of triamcinolone acetonide and chloramphenicol solution.Methods:Dionex C18(250 mm×4.6 mm,5 μm) column was adopted,the mobile phase consisted of 0.1 mol· L-1-heptanesulfonic acid sodium salt(including 0.1 mol·L-11-heptanesulfonic acid sodium salt,0.5 mol·L-1patassiumdihydrogen and 0.5% trithylamine,adjust pH=2.5 with phosphoric acid)(A)-methanol(B)with gradient elution 0 min(66%A)→20 min(66%A) →30 min(35%A)→49 min(35%A) →50 min(66%A) →60 min(66%A)] at the flow rate of 1.0 mL·min-1;the detection wavelength was 277 nm during 0-20 min and 230 nm during 20-60 min.Results:The linear response ranges of chloramphenicol,triamcinolone acetonide acetate and naphazoline hydrochloride were 30.375-3.000 mg·mL-1(r=0.9990),0.0127-0.1016 mg·mL-1(r=0.9989)and 0.0262-0.2096 mg·mL-1(r=0.9992).Conclusion:The result of determination is accurate and specific.This method is suitable for determination of the content and related substances of Triamcinolone Acetonide Acetate and Chloramphenicol solution.