Assessment of the Quality Control Parameters of Fixocard 50® & Amloten 50® Tablets Available in Bangladesh

Abstract

Hypertension is associated with increased risk of cardiovascular diseases. Having hypertension for short amounts of time is normal. However, when blood pressure stays high for most of the time, it can cause serious health problems. There are lots of classes of drugs are available for treatment including single and combination therapy. The rationale for combination therapy relates to the concept that antihypertensive efficacy may be enhanced when two classes of agents are combined as well as enhances tolerability, antagonize some of the adverse effects of the second drug, simplifies the treatment regimen, prevents treatment failures that might result from missed doses. The major objective of this study was to perform a qualitative evaluation of two commercially available brands (Fixocard 50® and Amloten 50®) of combined Atenolol (50mg) and Amlodipine (5mg) tablets marketed by local pharmaceutical companies in Bangladesh. All four batches of products met the quality specification specified in USP or BP in the weight variation, thickness, disintegration and dissolution. Two batches of products didn’t meet the specification of dissolution based on single tablets but based on average dissolution those tablets met the dissolution specification. Only one batch out of total batches didn’t meet the minimum specification of hardness test that should be at least 4 kg. Disqualification of this hardness test may results potential loss of products as they are not capable to overcome mechanical shock & pressure during manufacture, transport & handling process. Due to technical issue friability study couldn’t carry out. Conducting further study is necessary regarding the quality control parameters as these products are now becoming a potential choice of drugs for hypertension control.