Rapid Quantitative Determination Control Male Sexual Dysfunction Drug Content of Sildenafil and Tramadol Mixture by Spectrophotometry Along With Smart Chemometrics Approaches Compared to the HPLC Reference Method.

Abstract

There are reports for the simultaneous estimation of sildenafil (SIL) and tramadol (TM) using chromatographic techniques. Some limitations of these methods are high cost and time, more usage of pollutant solvents, and complicated instruments. Simultaneous determination of SIL and TM in the anti-sexual dysfunction pharmaceutical formulation using rapid and smart chemometrics approaches along with spectrophotometry. In this study, a spectrophotometric analysis method based on continuous wavelet transform (CWT), partial least-squares (PLS), and radial basis function neural network (RBF-NN) was presented. In the CWT method, the Symlet (Sym2) and Daubechies (db2) wavelet families with wavelengths of 268 and 221 nm were considered the best families for SIL and TM, respectively. The limit of detection (LOD) and limit of quantitation (LOQ) values were found to be 0.0185, 0.0054 μg/mL and 0.0458, 0.3092 μg/mL for SIL and TM, respectively. The mean recovery values were 101.06 and 101.49% for SIL and TM, respectively. The results of PLS revealed that the root-mean-square error (RMSE) of SIL and TM was 0.0286 and 0.0635, respectively. Also, the mean recovery of both drugs was obtained over 99%. The mean square error (MSE) of RBF-NN was 5.88 × 10-29 and 4.61 × 10-27 for SIL and TM, respectively. A statistical comparative study conducted for the proposed methods with the high-performance liquid chromatography (HPLC) technique demonstrated no significant difference between these methods. The suggested approaches were simple, fast, accurate, and affordable. Three smart UV spectrophotometric methods based on chemometrics were presented to determine SIL and TM simultaneously. The efficient chemometrics methods, including CWT, PLS, and RBF-NN, were used. The mentioned methods are rapid, simple, inexpensive, and accurate. The comparison was performed between the proposed models and HPLC technique.