THE PROCESS VALIDATION OF TABLET CONTAINING IRBESARTAN 300MG AND HYDROCHLOROTHIAZIDE 12.5mg

Zamir Hussain; Baqir Shyum Naqvi; Muhammad Iqbal Nasiri

Zamir Hussain Faculty of Pharmacy, Department of Pharmaceutics, Hamdard University, Karachi
Baqir Shyum Naqvi Faculty of Pharmacy, Department of Pharmaceutics, Hamdard University, Karachi
Muhammad Iqbal Nasiri Faculty of Pharmacy, Department of Pharmaceutics, Hamdard University, Karachi

Keywords: Process Validation, Tablet, Irbesartan, Hydrochlorothiazide

Abstract

The objective of this study was to understand about the process validation and process qualification of tablet containing Irbesartan 300mg and Hydrochlorothiazide 12.5mg. The quality of product depends upon the consistency in the quality parameters of the process. In this study three batches of tablet containing Irbesartan 300mg and Hydrochlorothiazide 12.5mg having batch No. A1, A2 and A3, with batch size of 500.00 tablets each were validated at the facility of PharmEvo (Pvt.) Ltd. All three batches were evaluated at the granulation stage for sieving, mixing time, final blending and content uniformity. The physical parameters like thickness, hardness, weight variation, friability and disintegration time and chemical parameters like assay and dissolution were evaluated at compression and coating stage. All the physical and the chemical parameters of the tablet were observed within the specification set by company during the development of formulations.