目的 建立高效液相色譜（HPLC）法測(cè)定瑞舒伐他汀鈣原料藥中有關(guān)物質(zhì)的方法。方法 采用HPLC法，Phenomenex Luna C₁₈ (2)色譜柱（250 mm×4.6 mm，5 μm），流動(dòng)相為水-乙腈-1%三氟乙酸水溶液（62：37：1），體積流量為1.0 mL/min，柱溫為40℃，進(jìn)樣量為20 μL，檢測(cè)波長(zhǎng)為242 nm。結(jié)果 系統(tǒng)和方法精密度RSD值均小于20%（n=6），瑞舒伐他汀鈣在0.020 1～0.201 3 μg線性關(guān)系良好（r=0.999 8），瑞舒伐他汀鈣的檢測(cè)限為2.76 ng，各雜質(zhì)氧化產(chǎn)物、內(nèi)酯、光降解產(chǎn)物Ⅰ和Ⅱ和非對(duì)映異構(gòu)體各雜質(zhì)的檢測(cè)限依次為1.85、1.32、1.08、1.11、2.06 ng。結(jié)論 本法合理嚴(yán)謹(jǐn)，精密度好，檢測(cè)靈敏度高，可有效用于瑞舒伐他汀鈣有關(guān)物質(zhì)檢測(cè)。

Objective To establish an HPLC method for detecting the related substances of rosuvastatin calcium.Methods HPLC was carried out on Phenomenex Luna C₁₈ (2) column (250 mm × 4.6 mm, 5 μm) with water-acetonitrile-1% trifluoroacetic acid (62:37:1) as mobile phase. The detection wavelength was 242 nm and injection volume was 20 μL at the flow rate of 1.0 mL/min. The column temperature was set for 40℃. Results The RSD values of method precision and system precision were less than 20% (n=6). The rosuvastatin calcium had a good linearity in the range of 0.020 1 μg-0.201 3 μg (r=0.999 8). The detection limit of rosuvastatin calcium was 2.76 ng and the detection limits of impurity were oxidation product (1.85 ng), rosuvastatin lactone (1.32 ng), photodegradation productⅠ (1.08 ng), photodegradation product Ⅱ (1.11 ng), non enantiomer (2.06 ng), respectively. Conclusion The method with good precision and high sensitivity could be used for detecting the related substances of rosuvastatin calcium.

國(guó)家科技重大專項(xiàng)資助項(xiàng)目（2011ZX09203-002)