Prucalopride- is a selective 5-HT 4 agonist used in the treatment of constipation which ischronic. It applies quality and good methods of analysis in its day to day quality control. Thespecified experiment was dedicated to the specific construction and experimentation of thequantitative estimation of Prucalopride in bulk and tablet dosage forms with Agilent ZorbaxC18 column with Phosphate buffer: Acetonitrile (70:30 v/v) at 1.0 mL/min and 239 nm wasproduced with the help of QbD based RP-HPLC. The optimized process was identified to beassociated with ICH Q2(R2) approaches of the solution and the retention time was estimatedto be 3.2 minutes. It was observed that range 80 and 120% was linear and their correlationcoefficient (r2) was 0.9999. The recovery of Prucalopride of 100.08% was found to be highlyprecise. With appropriate research, the precision of the method was found to be less than 2.0% and this means that the method is reproducible. The statistical significance of the modeldeveloped was revealed in the ANOVA results and CCD was a good method in determiningthe influence of acetyl nitrile concentration and flow rate on the retention time. A fast, precise,strong, and efficient QbD -empowered RP-HPLC technique of the estimation of Prucalopridehad been effectively created and validated. The use of CCD and reduced number ofexperiments ensured optimization of the methods. The developed approach may beimplemented in the quality control of the Prucalopride in the bulk and pharmaceuticalpreparation on a daily basis.
Sandhya Borse (Fri,) studied this question.