目的 建立反相HPLC法測(cè)定鹽酸米諾環(huán)素緩釋微丸膠囊中米諾環(huán)素的量和有關(guān)物質(zhì)。方法 Diamonsil C₁₈柱（200 mm×4.6 mm，5 μm），流動(dòng)相為醋酸銨緩沖溶液（pH 6.0）-乙腈-甲醇（80∶15∶5），檢測(cè)波長(zhǎng)為280 nm，體積流量為1.0 mL/min，柱溫為25℃，進(jìn)樣量為20 μL。結(jié)果 米諾環(huán)素在0.05～1 mg/mL線性關(guān)系良好（r＝0.999 7），方法精密度RSD為0.6%，平均回收率為99.46%，RSD為0.8%，各雜質(zhì)峰與主峰分離良好。結(jié)論 該方法簡(jiǎn)便，專屬性強(qiáng)，準(zhǔn)確可靠，可用于測(cè)定鹽酸米諾環(huán)素緩釋微丸膠囊中的米諾環(huán)素及有關(guān)物質(zhì)。

Objective To establish an HPLC method for the determination of minocycline hydrochloride and its related substances in minocycline hydrochloride sustained-release pellets capsules. Methods HPLC was performed on a Diamonsil C₁₈ column (200 mm × 4.6 mm, 5 μm) using ammonium acetate (pH 6.0)-acetonitrile-methanol (80:15:5) as the mobile phase at a flow rate of 1.0 mL/min. The detection wavelength was 280 nm and the column temperature was 25 ℃. Results The linear range of minocycline was 0.05—1 mg/mL (r = 0.999 7), precision RSD = 0.6%, and the average recovery was 99.46% (RSD = 0.8%). Conclusion The established method is simple, accurate, and specific, and could be used for the quality control of minocycline hydrochloride sustained-release pellets capsules.