Evaluation of the quality control parameters of different brands of paracetamol available in Bangladesh Pharma market

Abstract

Purpose: The research work was carried out to evaluate the quality control parameters of 15 different batches of 5 different brands of Paracetamol tablets available in Bangladesh pharma market by means of weight variation test, friability test, hardness test and disintegration test. Method: Forty six tablets of each batch of 5 different brands were collected from market and the physical parameters of these five brands were evaluated by means of weight variation, hardness, friability and disintegration test. The variation of the weight of individual tablet is a valid indication of the corresponding variation in the drug content and scheming tablet weights within the BP or USP limit contribute to better tablet hardness and friability. Hardness is the second most important physical facet for assessing tablet which indicates the capability of a tablet to withstand mechanical shocks during handling in manufacturing, packaging and shipping. Friability test is essential to evaluate the ability of a tablet to withstand abrasion in packing, handling and transporting as well as disintegration test is crucial physical feature which is considered as the first step toward dissolution. Result: The weight variation of three different batches of ACE tablet (1100304, 1100274 and 1110202), FAST tablet (XC1099, XC1021 and XC1076) and XCEL tablets (LE31, KE125 and OE136) comply with the specification mentioned in the USP and pass the quality control parameter. The weight variation of two different batches of XPA tablet did not comply with the USP specification. Batch 11L33 comply with the USP specification but batch 11128 and batch 12A03 did not comply with the USP specification. The weight variation of three different batches of SERVIGESIC tablet (2017, 1998 and 8914) complies with the specification mentioned in the USP and passes the quality control parameter. All three batches of ACE (1100304, 1100274 and 1110202), FAST (XC1099, XC1021 and XC1076), XCEL (LE31, KE125 and OE136), XPA (11L33, 11128 and 12A03) and SERVIGESIC (1998, 8914 and 2017) have a hardness greater than 4kg and, therefore, meet the USP XII specification and pass the quality control parameter. All three batches of ACE (1100304, 1100274 and 1110203), FAST (XC1099, XC1021), XCEL (LE31, KE125 and OE136), XPA (11L33, 11128 and 12A03) and SERVIGESIC (1998, 8914 and 2017) have met the USP specification and passed the friability test. However XC1076 batch of FAST brand does not meet the USP specification. On the other hand all three batches of ACE tablets (1100304, 1100274, 1110202), FAST (XC1099, XC1021 and XC1076), XCEL (LE31, KE125 and OE136), XPA (11L33, 11128 and 12A03) and SERVIGESIC (1998, 8914 and 2017) have met the USP specification and passed the disintegration test. Conclusion: Quality control parameters or physical properties of tablet are useful tools for better quality of medicines and for maintaining consistency in batch-to-batch manufacturing and it should be performed for every drug product. From this study it was observed that except two batch of XPA and one batch of FAST all the different brands of paracetamol meet the quality control parameter specifications. This study revealed that all the quality control parameters are closely related to each other and since all the quality control tests did not conducted in this study, further studies are needed to assess the quality of the products.