Comparative evaluation of different mathematical models for simultaneous UV spectrophotometric quantitative analysis of velpatasvir and sofosbuvir.

Velpatasvir and sofosbuvir are new drugs prescribed in a combined pharmaceutical dosage form that pose a new challenge for the treatment of chronic hepatitis C. In this work, a comparative evaluation of the classical mathematical model, simultaneous equations, and the advanced mathematical model, partial least squares, for the spectrophotometric quantitative analysis of velpatasvir and sofosbuvir in bulk powder and in the new combined pharmaceutical dosage form was presented. The mathematical simultaneous equation method was used to resolve the overlap between velpatasvir and sofosbuvir. The absorbance and absorbativity values at 255 and 244.8 were used to construct two mathematical equations required for spectrophotometric quantitative analysis of the drugs under study. Partial least squares, an advanced mathematical tool dealing with the full spectral data of velpatasvir and sofosbuvir, was also introduced. An experimental design for the calibration sets and validation sets for the binary mixture of the drugs under study were created. The model was optimized based on a five-level, two-factor experimental design. Pre-processing of the spectral data was applied and resulted in the exclusion of the spectral region from 200 to 230 nm due to noise. The described methods were successfully applied to the spectrophotometric quantitative analysis of velpatasvir and sofosbuvir in Epclusa® tablets.

Analysis of the ternary antiretroviral therapy dolutegravir, lamivudine and abacavir using UV spectrophotometry and chemometric tools.

Herein, a simple spectrophotometric method coupled with chemometric techniques i.e. partial least square (PLS) and genetic algorithm (GA) were utilized for the simultaneous determination of the vital ternary antiretroviral therapy dolutegravir (DTG), lamivudine (LMV), and abacavir (ACV) in their combined dosage form. Calibration (25 samples) and validation (13 samples) sets were prepared for these drugs at different concentrations via implementing partial factorial experimental designs. The zero order UV spectra of calibration and validation sets were measured and then subjected for further chemometric analysis. Partial least squares with/without variable selection procedures i.e. genetic algorithm (GA) were utilized to untangle the UV spectral overlapping of these mixtures. Cross-validation and external validation methods were applied to compare the performance of these chemometric techniques in terms of accuracy and predictive abilities. It was found that six latent variables were optimum for modelling DTG, four latent variables for modelling LMV and three latent variables for modelling ACV. Although, good recoveries with prompt predictive ability were attained by these PLS, GA-PLS showed better analytical performance owing to its capability to remove redundant variables i.e. the number of absorbance variables have been reduced to about 21-29%. The proposed chemometric methods can be reliably applied for simultaneous determination of DTG, LMV, and ACV in their laboratory prepared mixtures and pharmaceutical preparation posing these chemometric methods as worthy and substantial analytical tools in in-process testing and quality control analysis of many antiretroviral pharmaceutical preparations.

D-optimal design as a useful tool response surface methodology for the optimization of signals from synchronous fluorescence prior to simultaneous determination of avanafil and tadalafil.

A rapid, smart and sensitive first derivative spectrofluorimetric method has been carried out for the simultaneous estimation of avanafil and tadalafil either in their pure form, tablet dosage form or spiked human plasma. The measurements of normal emission spectra or synchronous fluorescence intensity of both drugs show severe overlap which hindered their determination using normal fluorescence or synchronous intensity. Therefore, a highly sensitive first derivative synchronous fluorescence procedure was used to resolve this overlap. The method is based upon measurement of the amplitude of the first derivative of synchronous fluorescence intensity of both drugs at Δλ = 70 nm and at suitable wavelength of 396 nm and 364 nm for avanafil and tadalafil, respectively. Under the optimum conditions, the linear determination ranges are 50-1800 and 5-400 ng mL-1 with a detection limit of 12.93 and 1.46 ng mL-1 for avanafil and tadalafil, respectively. A response surface methodology was used for optimization using D-optimal design which can be used for determination of the exact optimum parameters specifically designed for this method. In addition; it is a good way to graphically clarify the relationship between various experimental variables and the synchronous fluorescence intensity.