Safwan Ashour,Soulafa  Omar,
New Validated Analytical Method for Determination of Simvastatin in Tablet Formulations by RP–HPLC
Drug and Drug Abuse
2020
2674-5062
http://dx.doi.org/10.31487/j.DDA.2010.01.02
https://www.sciencerepository.org/new-validated-analytical-method-for-determination-of-simvastatin_DDA-2020-1-102 
Abstract: RP–HPLC method has been developed and validated for the determination of simvastatin (SVS) in pure
form and in tablets. Fluvastatin sodium was used as internal standard. The determination was performed on
Nucleodur column C8 (250×4.6 mm i.d., 5 µm particle size); the mobile phase consisted of a mixture of
phosphate buffer solution (KH2PO4 0.05 M, pH 4.83) and methanol (20:80, v/v), pumped at a flow rate 1.0
mL min−1
. Analyte was monitored by UV detection at 230 nm. The mean retention times for fluvastatin and
simvastatin were about 4.40 and 9.00 min, respectively. The method was proved linear in the range of 3.5–
550.0 µg mL-1
and exhibited good correlation coefficient (r>0.9998) and excellent mean recovery (100.71–
102.18%). Very good limit of detection of 0.63 µg mL-1 was found for SVS. The method was validated
statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. This method
was successfully applied to the determination of simvastatin content in four marketed brands from Syria. A
good agreement between this method with the pharmacopoeial method for the determination of simvastatin
in some real samples demonstrates that the proposed method is suitable to quantify simvastatin in
pharmaceutical formulations.Keywords: Simvastatin, high–performance liquid chromatography, tablets