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,5 μm)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 ;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。

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 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.

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