Optimized Differential Derivative UV Spectrophotometric Assay For Enhanced Accuracy In Orlistat Quantification

ABSTRACT A novel and validated UV spectrophotometric method using differential derivative techniques was developed for the quantification of Orlistat in pharmaceutical formulations. The method was assessed based on various analytical parameters, including linearity, precision, accuracy, sensitivity, ruggedness, and robustness. The assay results indicated a percentage recovery of 98.74%, confirming compliance with Pharmacopeial standards. Linearity studies showed high correlation coefficients (r² ≥ 0.999) for zero-order, first-order, and second-order derivative methods, ensuring reliable quantification. Precision and repeatability assessments demonstrated low relative standard deviation (%RSD) values, indicating excellent reproducibility. Recovery studies revealed percentage recoveries between 109.81% and 131.16%, highlighting the method's accuracy. Sensitivity analysis, expressed through the limits of detection (LOD) and quantification (LOQ), confirmed the method’s capability to detect low drug concentrations. Ruggedness and robustness evaluations showed that minor variations in experimental conditions did not significantly impact the method’s performance. The validated UV spectrophotometric approach is simple, precise, and cost-effective, making it suitable for routine quality control of Orlistat formulations. Keywords: Orlistat, UV Spectrophotometry, Derivative Spectroscopy, Optimization, Validation.