Optimization

ABSTRACTA 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.

Telmisartan is an angiotensin II (AT1) receptor antagonist used in the treatment of hypertension. The drug is practically insoluble in water and insoluble in the pH range 3-9. The principal aim of this work is to improve the dissolution profile of telmisartan by solid dispersion and to find out the effect of sodium starch glycolate and β – cyclodextrin on the dissolution profile of telmisartan tablets. The study also includes optimization of the amount of sodium starch glycolate and β – cyclodextrin by a 32 full factorial design. Other excipients used in the study are microcrystalline cellulose (Avicel PH-101), D- mannitol, magnesium stearate and talc. Both sodium starch glycolate and β – cyclodextrin had contribution towards the enhanced release profile of telmisartan (about 80 % drug is released in 40 minutes) but the effect of β – cyclodextrin is more pronounced as revealed from response surface plots as well as from their corresponding contour plots. The optimized amount of β – cyclodextrin and sodium starch glycolate was found to be 2.0 gm and 1.6 gm respectively. The predicted and observed responses for the optimized solid dispersions shown no significant difference (paired t-test, p – value = 0.2834 and 0.3403 for percentage drug released at 20 and 40 minutes respectively).