Die Pharmazie is published by IMR Press from Volume 81 Issue 1 (2026). Previous articles were published by another publisher under the CC-BY licence, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement.
Development and validation of an HPLC method to be used for simultaneous detection and quantification of different statins after ex vivo skin diffusion studies
M. N. Sithole 1, E. Oosthuysen 2, J. Van Jaarsveld 2, J. L. Du Preez 2, J. Du Plessis 2, M. Gerber 3
Affiliations
Article Info
1 Centre of Excellence for Pharmaceutical Sciences (Pharmacen™), Cape Town, South Africa; North-West University, Potchefstroom; Afrigen Biologics (Pty) Limited, Cape Town, South Africa
2 Centre of Excellence for Pharmaceutical Sciences (Pharmacen™), Cape Town, South Africa
3 Centre of Excellence for Pharmaceutical Sciences (Pharmacen™), Cape Town, South Africa;, Email: Minja.Gerber@nwu.ac.za
Abstract
A novel high performance liquid chromatography (HPLC) method was developed and validated to simultaneously analyse all statins currently available globally (atorvastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin). A Venusil XBP C18(2) reverse phase column (150 x 4.6 mm) with a 5 μm particle size was used. The gradient conditions started at 25% acetonitrile, which linearly increased to 90% after 1.0 min, held at 90% until 6.5 min, and lastly, re-equilibrated to starting conditions. The mobile phase consisted of acetonitrile/water and 0.005 M (0.2%) octane sulphonic acid-Na (pH 3.5). The flow rate was set at 1.0 ml/min with a 10 μl injection volume. The HPLC method indicated linearity (R2 =0.9999) within the concentration range of 0.2-206.4 μg/ml. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be within the permissible criteria of ≤15% and ≤20%, respectively. Following an appropriate investigation of all the parameters for method validation, it was confirmed that the HPLC method was successfully validated and proven to be accurate to simultaneously quantify statins even in combination with other excipients used during the formulation of nano-emulsions and nano-emulgels.
