Table 1.
Percentage of artesunate and amodiaquine anti-malarial tablet per blisterpack manufactured by GPCL and LPL determined by methods in International Pharmacopoeia monograph
|
Anti-malarial blisterpack identification number |
Percentage of artesunate per tablet (%) |
Classification based on PhInt acceptable range of 96/98 – 102% |
Percentage of amodiaquine per tablet (%) |
Classification based on PhInt acceptable range of 90 – 110% |
|
|---|---|---|---|---|---|
| HPLC | Titrimetric | Spectrophotometry | |||
| G1 |
66.4 |
92.8 |
Failed |
102.3 |
Passed |
| G2 |
78.1 |
90.0 |
Failed |
99.4 |
Passed |
| G3 |
85.3 |
92.2 |
Failed |
104.9 |
Passed |
| G4 |
92.0 |
92.2 |
Failed |
102.5 |
Passed |
| G5 |
108.9 |
101.1 |
Passed |
101.5 |
Passed |
| G6 |
84.4 |
92.2 |
Failed |
105.2 |
Passed |
| G7 |
109.2 |
92.8 |
Failed |
105.4 |
Passed |
| G8 |
81.12 |
92.8 |
Failed |
100.4 |
Passed |
| G9 |
99.3 |
92.2 |
Failed |
100.5 |
Passed |
| G10 |
84.2 |
94.4 |
Failed |
103.0 |
Passed |
| L1 |
102.1 |
106.7 |
Failed |
103.1 |
Passed |
| L2 |
114.2 |
103.9 |
Failed |
103.6 |
Passed |
| L3 |
97.1 |
100.0 |
Passed |
106.0 |
Passed |
| L4 |
102.6 |
106.1 |
Failed |
95.2 |
Passed |
| L5 |
93.7 |
96.7 |
Passed |
5.1 |
Failed |
| L6 |
92.1 |
93.9 |
Failed |
96.7 |
Passed |
| Artstd/Amdstd* | 100 | 100.0 | Passed | 100* | Passed* |
Each anti-malarial blisterpack contains amodiaquine and artesunate tablets. Meaning of abbreviations: G1 to G10 refers to anti-malarial blisterpacks obtained from GPCL, whilst L1 to L6 were obtained from LPL; Artstd refers to artesunate standard ICRS1409 obtained from EMDQ, Strasbourg, France); Amdstd* amodiaquine standard ICRS0209 obtained from EMDQ, Strasbourg, France). PhInt refers to International Pharmacopoea. Note that HPLC was not done for amodiaquine because it is not recommended in the International Pharmacopoea monograph.