A novel of derivative spectrophotometry as rapid and accurate method in application of simvastatin co-crystal assay

Abstract

The objective of this study was to obtain a rapid and valid method of quantitative analysis for the determination simvastatin (SV) in combination with saccharin (SAC) and aspartame (ASP) in the co-crystal form using derivative spectrophotometric. Co-crystal preparation was conducted using solvent drops grinding (SGD). Samples of each co-crystal of ASP and SAC were dissolved in a solvent mixture of the methanol-water with a ratio (60:40); afterward it was derived using the zero crossing order for determining level of SV. The analytical method was validated based on validation parameter requirements, including, linearity, range, accuracy, precision, limit of detection (LOD) and the limit of quantitation (LOQ). The derivate spectrometric method have exhibited the zero crossing order in the third order derivate at 251 nm, linearity studies showed the value r²=0.9998 in a concentration range 0.25-2μg/ml. The accuracy was presented by the %recovery = 98.69%- 103.74%, and precision (%RSD) =1.67% - 2.96%. LOD and LOQ results   presented a value 0.096 and 0.32μg/ml, respectively. Derivative spectrophotometric has been applied to the SV determination in co-crystal form and fulfilled all requirement of a method validation.