Derivative spectrophotometric method for simultaneous determination of zofenopril and fluvastatin in mixtures and pharmaceutical dosage forms

• A new method was developed for the determination of zofenopril and fluvastatin.
• The analytical method has been validated according to the ICH recommendations.
• Our method was applied for the analysis of drugs in the mixtures and dosage forms.

Fast, accurate and precise method for the determination of zofenopril and fluvastatin was developed using spectrophotometry of the first (D1), second (D2), and third (D3) order derivatives in two-component mixtures and in pharmaceutical preparations.It was shown, that the developed method allows for the determination of the tested components in a direct manner, despite the apparent interference of the absorption spectra in the UV range. For quantitative determinations, “zero-crossing” method was chosen, appropriate wavelengths for zofenopril were: D1 λ = 270.85 nm, D2 λ = 286.38 nm, D3 λ = 253.90 nm. Fluvastatin was determined at wavelengths: D1 λ = 339.03 nm, D2 λ = 252.57 nm, D3 λ = 258.50 nm, respectively.The method was characterized by high sensitivity and accuracy, for zofenopril LOD was in the range of 0.19–0.87 μg mL−1, for fluvastatin 0.51–1.18 μg mL−1, depending on the class of derivative, and for zofenopril and fluvastatin LOQ was 0.57–2.64 μg mL−1 and 1.56–3.57 μg mL−1, respectively. The recovery of individual components was within the range of 100 ± 5%. For zofenopril, the linearity range was estimated between 7.65 μg mL−1 and 22.94 μg mL−1, and for fluvastatin between 5.60 μg mL−1 and 28.00 μg mL−1.

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