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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。
Objective: To establish a HPLC method for the determination of three components chloramphenicol, naphazoline hydrochloride and triamcinolone acetonide acetate and related substances (triamcinolone acetonide, chloramphenicol diol and Nitrobenzaldehyde) content. Methods: A Dionex C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of 0.01 mol·L -1 sodium heptane sulfonate solution (6.8 g potassium dihydrogen phosphate and 0.01 mol·L -1 heptane Sodium sulfonate solution and dilute to 1000 mL, add 5 mL of triethylamine, mix and adjust to pH 2.5 with phosphoric acid (A) - methanol (B), gradient elution [0 min (66% A) → 20 (66% A) → 30 min (35% A) → 49 min (35% A) → 50 min (66% A → 60 min (66% A)]; the flow rate was 1.0 mL · min -1; : 277 nm at 0-20 min and 230 nm at 20-60 min. Results: The linear ranges of chloramphenicol, naphazoline hydrochloride and triamcinolone acetonide were 0.375 ~ 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 HPLC method established in this paper is accurate, reliable and specific. It can be used as a control method for triamcinolone acetonide chloramphenicol solution and related substances.