Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin and simvastatin.
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.
Pharmaceutical Products Department, Federal University of Minas Gerais, Av. Pres. Antônio Carlos, 6627, Belo Horizonte, 31270-901, MG, Brazil.
Taízia D
TD
Silva
Marcelo A
MA
Oliveira
Renata B
RB
de Oliveira
Cristina D
CD
Vianna-Soares
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000032:analysis* / Q000737:chemistry; D016014:Linear Models; D008148:Lovastatin / Q000032:analysis / Q000737:chemistry; D009281:Naphthalenes / Q000032:analysis* / Q000737:chemistry; D017035:Pravastatin / Q000032:analysis / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019821:Simvastatin / Q000032:analysis / Q000737:chemistry
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D009281:Naphthalenes; D008148:Lovastatin; D019821:Simvastatin; D017035:Pravastatin