Abstract
Purpose: To develop and validate an
accurate, rapid and reproducible reversed-phase high
performance liquid chromatography (RP-HPLC) analytical
method for the lipid lowering drug, simvastatin, and to
apply the developed method to study the solubility of
the drug in various oils and surfactants.
Methods: Isocratic RP-HPLC system
with a UV-vis detector, and a column with dimensions 4.6
mm x 150 mm and 5µ particle size, was employed. The
mobile phase consisted of methanol and 0.01M KH2PO4
phosphate buffer (80:20) at pH 5.5 adjusted with
phosphoric acid (2M) and pumped at a flow rate of 1
ml/min. Validation parameters, viz, limit of
detection (LOD), limit of quantification (LOQ)
linearity, accuracy, precision, and sensitivity, were
established. Solubility study was performed in various
oils and surfactants at 25 °C and the developed HPLC
method was applied to analyze all samples.
Results: The developed HPLC method
showed good linearity (R2 = 0.9958 ± 0.0040.
The intra- and inter-day % accuracy was more than 98 %.
LOQ and LOQ were 0.160 and 0.484 μg/ml respectively.
Simvastatin showed the highest solubility in sesame oil
(15 mg/ml) and in Tween 80 (11 mg/ml) at 25 oC.
Conclusion: An accurate, rapid and
robust HPLC-UV method has been developed, validated and
applied successfully to determine the solubility of
simvastatin in oils.
Keywords:
Simvastatin, Validation, Solubility, Sesame oil, Tween
80.
