Abstract

Sureshee Mekala Liyanaarachchi*, Walisinghe Pathirana, Sujatha Hewage, Prasanna Senadheera and Chamari Obeysekera

ABSTRACT

Purpose: The study proposes a model ‘Twin Batch Analysis Protocol’ for the speedy determination of product quality. The quality of two batches of paracetamol tablets combined in a 1: 1 proportion was determined considering it as a single batch. The analytical work load in high throughput products could be reduced by almost 50%. Methods: The analytical data of past records from a pool of 80 batches extending over an eight-year period were compared with actually generated analytical data of 40 batches to determine the consistency of product quality. Under twin batch analysis, data generated from individual analysis of two tablet batches were compared with the results of twin batch analysis data of the same two batches combined together in a 1:1 proportion. Results: Deviation of results between the two batches involved in conventional single batch analysis and twin batch analysis in all parameters (not applicable to dissolution) were less than 3%. Successful determination of assay values of blinded samples prepared with different strengths of paracetamol confirmed the integrity of the analyst. Conclusion: The procedure set out here could be considered as a useful model “Twin Batch Analysis Protocol' that could be adopted by the pharmaceutical industry. It suits products that are manufactured in a large number of batches reducing the analytical work load by 50%.