Abstract
PurposeThe objective of the current study is to evaluate the Ultra Performance Liquid Chromatography (UPLC) method for quantification of Acyclovir in lipid-based formulations. MethodA simple, rapid, reliable and precise reversed phase UPLC method has been developed and validated according to the regulatory guidelines, which composed of isocratic mobile phase; 0.25% formic acid (FA) in Milli-Q water with a flow rate of 0.5ml/min, and column BEH C18 (2.1×50mm, 1.7μm). The detection was carried out at 254nm. ResultsThe developed UPLC method was found to be rapid (1.2min run time), selective with well resoluted Acyclovir peak (0.89min) from different lipid matrices and sensitive (Limit of Detection (LOD) was 0.3ppm and Lower Limit of Quantification (LLOQ) was 1ppm). The accuracy and precision were determined and were perfectly matching with the standard FDA limits. ConclusionThe study showed that the proposed UPLC method can be used for the assessment of drug purity, stability, solubility and lipid-formulation release profile with no interference of excipients or related substances of active pharmaceutical ingredient.
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