A NEW SINGLE STABILITY INDICATING RP-ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (RP-UPLC) METHOD FOR EVALUATION OF ASSAY OF BICALUTAMIDE FROM DOSAGE FORM AND SUITABILITY OF METHOD FOR DETERMINATION OF DISSOLUTION RATE AND RESIDUE ANALYSIS.

摘要

A new single stability-indicating isocratic reversed phase ultra-performance liquid chromatographic (RP-UPLC) method with a shortest run time of 2.5 minutes is developed for the determination of assay of bicalutamide an anti-cancer drug from its finished dosage form in the presence of its forced degradation products. The method is developed using Waters Aquity BEH C18 column with mobile phase containing an isocratic mixture of solvent A and B. The eluted compounds were monitored at 270 nm. Bicalutamide tablets were subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation, within which forced degradants were well-resolved from main peak, thus proving the stability indicating power of the method. The developed method is validated as per ICH guidelines with respect to specificity, linearity, Accuracy, precision and robustness. The same method is also tested for evaluation of dissolution where recovery, linearity and solution stability were evaluated and found satisfactory. As a part of cleaning validation-Residue analysis, recovery of 0.5ppm on two different surfaces (Stainless steel and Class-A Glass) were performed and found satisfactory along with limit of Quantification with signal to noise greater than 10