European Journal of Biomedical and Pharmaceutical Sciences

PROCESS VALIDATION OF THE AZITHROMYCIN TABLETS 500 MG

Surendra Kumar Yadav*, Kashif Hussain and Praveen Kumar Ashok

ABSTRACT

Azithromycin achieves prolonged, high tissue concentrations in spite of low serum levels and obviously must be active at tissue sites of infection to be effective. Although validation studies have been conducted in the pharmaceutical industry for a long time, there is an ever increasing interest in validation owing to their industry’s greater emphasis in recent years on quality assurance program and is fundamental to an efficient production operation. The angle of repose was calculated by using the equation. it ranged from 21-30. The compressibility index of all ingredients were determined by equation. It ranged from 1-20. The Hausner’s Ratio of all ingredients were determined by equation. It ranged from 1 – 1.50. Prepared tablets ware evaluated for post compression parameters like thickness and diameter, hardness, friability, disintegration time, drug content. Thickness and diameter of tablets were accurately measured by using digital Vernier caliper for desired uniformity in size and shape. Active concentration and prolonged retention of azithromycin by phagocytic cells should allow delivery and subsequent release of accumulated drug at sites of infection. Process Validation of batches has been completed. The results of batches was found well within the defined limits.

Keywords: Pharmaceutical Drug, Azithromycin, Validation, Process Validation.