Silva Taízia D, Oliveira Marcelo A, de Oliveira Renata B, Vianna-Soares Cristina D
Pharmaceutical Products Department, Federal University of Minas Gerais, Av. Pres. Antônio Carlos, 6627, Belo Horizonte, 31270-901, MG, Brazil.
J Chromatogr Sci. 2012 Oct;50(9):831-8. doi: 10.1093/chromsci/bms079. Epub 2012 Jun 11.
Statins are effective and often-prescribed drugs for the treatment of hypercholesterolemia. This study shows a simple and fast method validation by reversed-phase high-performance liquid chromatography in the linear range 28 to 52 µg/mL to quantify lovastatin, pravastatin sodium or simvastatin in bulk drug or dosage forms. Statins were determined using a C8 endcapped column (250 × 4 mm, 5 µm), isocratic mobile phase of acetonitrile and 0.1% phosphoric acid (65:35), 30°C, ultraviolet-diode array detection at λ 238 nm and 1.5 mL/min flow for lovastatin and simvastatin and 1.0 mL/min for pravastatin sodium. The developed method is fast, simple, reliable and shows appropriate linearity (r > 0.999), accuracy (98.8-101.6%), precision (relative standard deviation <2%) and selectivity toward placebo and/or degradation products in very similar chromatographic conditions for all statins.
他汀类药物是治疗高胆固醇血症的有效且常用药物。本研究展示了一种通过反相高效液相色谱法进行的简单快速的方法验证，该方法在28至52 µg/mL的线性范围内，用于定量原料药或剂型中的洛伐他汀、普伐他汀钠或辛伐他汀。使用C8封端柱（250×4 mm，5 µm）测定他汀类药物，乙腈和0.1%磷酸（65:35）的等度流动相，30°C，在238 nm波长处进行紫外-二极管阵列检测，洛伐他汀和辛伐他汀的流速为1.5 mL/min，普伐他汀钠的流速为1.0 mL/min。所建立的方法快速、简单、可靠，在所有他汀类药物非常相似的色谱条件下，显示出适当的线性（r>0.999）、准确度（98.8 - 101.6%）、精密度（相对标准偏差<2%）以及对安慰剂和/或降解产物的选择性。
