Quality and Brands of Amoxicillin Formulations in Nairobi, Kenya
Table 7
Content determination and dissolution test results for amoxicillin/clavulanic acid tablets.
Sample code
Country of origin
Labelled active ingredients (mg)
Chemical content as % label claim (RSD)
Dissolution chemical content as % label claim (RSD)
Clavulanic acid
Amoxicillin
Clavulanic acid
Amoxicillin
Control
United Kingdom
625
94.00 (0.99)
95.00 (1.46)
101 (1.44)
94.00 (0.76)
KAN95
India
375
99.82 (0.59)
93.13 (0.29)
88.70 (3.40)
97.40 (2.80)
SB36
India
375
115.57 (1.37)
87.81 (1.24)
ND
ND
CBD131
India
625
105.81 (0.35)
99.84 (0.39)
77.60 (7.90)
88.10 (8.6)
KBR90
India
625
97.80 (0.50)
93.40 (0.44)
75.2 (1.61)
77.50 (1.97)
SB57
India
625
98.04 (1.19)
92.13 (0.31)
88.0 (4.80)
87.60 (4.20)
CBD136
India
625
113.00 (1.28)
84.81 (1.60)
ND
ND
RSD: relative standard deviation; USP limits: content determination for amoxicillin at ~90%-120% and clavulanic acid at 90%-125% of label claim. Dissolution: NLT 85% for amoxicillin and NLT 80% for clavulanic acid of label claim; ND: not done.
