Spectrophotometric determination of olanzapine, fluoxetine HCL and its impurity using univariate and chemometrics methods reinforced by latin hypercube sampling: Validation and eco-friendliness assessments

Abstract

Abstract Novel univariate and chemometrics-aided UV spectrophotometric methods were tailored to undergo the fundamentals of green and white analytical chemistry for the simultaneous estimation of a ternary mixture of olanzapine (OLA), fluoxetine HCL (FLU), and its toxic impurity 4-(Trifluoromethyl) phenol (FMP) without any prior separation. The dual-wavelength ratio spectrum univariate method was used to determine OLA and FLU in the presence of FMP in the range of (4–20) and (5–50) μg/ml, respectively. In compliance with the International Conference on Harmonization (ICH) standards, the technique was validated and established Remarkable accuracy (98–102%) and precision ( 0.05) among the proposed and published techniques. Both pure powders and pharmaceutical capsules were analyzed via these methods.

Keywords

• Olanzapine/fluoxetine HCL combination
• 4-(Trifluoromethyl) phenol toxic impurity
• UV spectrophotometry
• Chemometrics
• Latin hypercube sampling technique
• Comprehensive sustainability evaluations