EVALUATION OF THE QUALITY ASSURANCE OF FIVE BRANDS AMOXICILLIN TRIHYDRATE CAPSULES SOLD IN THE OPEN DRUG MARKET AT NSUKKA

EVALUATION OF THE QUALITY ASSURANCE OF FIVE BRANDS AMOXICILLIN TRIHYDRATE CAPSULES SOLD IN THE OPEN DRUG MARKET AT NSUKKA

ABSTRACT

The active drug content and weight uniformity of five brands (A – E) of Amoxicillin Trihydrate capsules in Nsukka open drug market were evaluated to ascertain their quality assurance using UV visible spectroscopy and gravimetry. This study has shown that all the brands analyzed showed significant variations with respect to active drug content determination for the three brands B, D and E. Using United State Pharmacopoeia (USP) and British Pharmacopoeia (BP) specifications of 90 – 110 %, the values obtained were B – (413.525 mg), D – (440.325 mg), E – (414.100 mg). These values were within the general drug acceptance limit of 80 – 110 % but failed the antibiotic amoxicillin trihydrates USP and BP specifications with acceptable limit of 90 – 110 % determined at 266 nm. The percentage mean content of all the brands (A – E ) were 77.64, 82.80, 74.24, 88.07 and 82.82. All the brands pascsed the weight uniformity test with coefficient of variation CV value range of ± 0 – 5 % for capsules more than 250 mg according to USP and BP specifications. However, with the result obtained, the consequences are that it poses a serious threat to the health of the entire people of West Africa sub regions that depend on these drugs for therapeutical response. As all the drugs assayed were below the acceptance limit requirement of antibiotic amoxicillin trihydrate and thus, can lead to serious health implications such as drug resistance, cardiac failure, etc. Drug regulatory bodies should be at alert and they should conduct strict routine check on all the NAFDAC satisfied companies as all the drugs analyzed compromise their quality because of profit reasons.