The present research work focused on prospective process validation for Losartan potassium tablets 50mg. The tablets were manufactured by wet granulation method. Since the dose is 50mg, uniform distribution of the drug in the tablet is critical which can influence the content uniformity, assay and dissolution of the tablets. The critical parameters selected for process validation were dry mixing, blending, lubrication and compression. Uniformity of dry mixing was found to be excellent after 20 minutes because %RSD was less than 2.0%. The content uniformity after 15 minutes of blending was satisfactory since the % RSD was less than 1.5%. Physical parameters and assay at compression stage, i.e different turret speeds (20, 25 and 30 rpm), different hopper levels (Full hopper, half hopper and quarter hopper) and different time intervals (Initial, Middle and End) were within limits. Based on results at each critical stage for the specified parameters, it is concluded that the wet granulation method can ensure uniform distribution of Losartan potassium and the tablets can be effectively manufactured with the desired specifications& reproducible quality standards.
Prospective Process Validation, Losartan potassium tablets, Wet granulation
Cite This Article
Vinod J. (2014). Prospective Process Validation of Losartan Potassium Tablets 50mg. International Journal for Pharmaceutical Research Scholars. 3(1), 345-362.