Evaluation of the Quality of Artemisinin-Based Antimalarial Medicines Distributed in Ghana and Togo
Table 3
Percentage composition and milligram quantities of active pharmaceutical ingredient (API) of a selection of samples from Ghana and Togo by SQ-TLC and HPLC and comparison of results with the stated manufacturer’s claim and pharmacopoeia requirements.
Code
Manufacturer’s label claim
Semiquantitative TLC estimation of composition in % and mg quantities of dosage forms of the API (in bold) compared to the manufacturer’s label claim range of dosage forms ( = 6)
Remarks based on SQ-TLC results
HPLC determination of composition of API in % and mg quantities ( = 6)
Remarks based on HPLC results
Solvent system 1
Solvent system 2
% range ± rsd
Quantity (mg)
% range ± rsd
Quantity (mg)
% ± rsd
Quantity (mg)
Samples from Ghana
3N1
ATS/AMQ: 100/270 mg
70–75 ± 0
70–75
70–75 ± 0
70–75
NC
70.62 ± 2
70.62
NC
3N1
ATS/AMQ: 100/270 mg
81.0–86.0 ± 2
218.7–232.2
82.5–87.5 ± 3
222.5–236.3
NC
95.55 ± 0.96
257.99
C
3N7
ATS: 50 mg oral
Not detected
Not detected
Not detected
Not detected
NC
Not detected
Not detected
NC
ATS/AMQ: 100/270 mg coformulated
77.5–82.5 ± 3
77.5–82.5
76–81 ± 2
76–81
NC
83.46 ± 1
83.46
NC
ATS/AMQ: 100/270 mg coformulated
101.5–106.5 ± 2
274.1–287.6
100.5–106.5 ± 2
274.1–287.6
C
101.77 ± 2
274.8
C
ATM/LUM: 80/480 mg coformulated
89–94 ± 3
71.2–75.2
88–93 ± 2
70.4–74.4
C
96.8 ± 2
77.44
C
ATM/LUM: 80/480 mg coformulated
86–91 ± 2
412.8–436.8
88–93 ± 3
422.6–446.4
C
93.91 ± 4
450.77
C
5P1
ATM 80 mg/1 mL injection
87.5–92.5 ± 0
70–74
90–95 ± 0
72–76
BLC
94.04 ± 3
75.23
BLC
DHA: 60 mg
70–75 ± 0
42–45
68–73 ± 4
40.8–43.8
NC
80.75 ± 2
48.45
NC
DHA/PPQ: 40/320 mg coformulated
81–86 ± 2
32.4–34.4
84–89 ± 2
33.6–35.6
BLC
85.69 ± 1
34.28
NC
Samples from Togo
1N11
ATS: 50 mg oral
60–70 ± 6
30–35
60–70 ± 6
30–35
NC
67.07 ± 2.4
33.54
NC
3N8
ATS: 50 mg oral
55–65 ± 6
27.5–32.5
54–64 ± 6
27–32
NC
60.34 ± 1.06
30.17
NC
1M3
ATS/AMQ: 100/270 mg
67–77 ± 6
67–77
70–80 ± 5
70–80
NC
71.92 ± 2.07
71.92
NC
1M3
ATS/AMQ: 100/270 mg
90–100 ± 4
243–270
86.5–96.5 ± 4
233.55–260.55
C
95.2 ± 0.86
257.04
C
1R16
ATM: 80 mg/1 mL injection
74–84 ± 6
59.2–67.2
70–80 ± 14
56–64
NC
93.14 ± 2.06
74.51
BLC
1RM5
ATM: 80 mg/1 mL injection
90–100 ± 0
72–80
85–95 ± 8
68–76
BLC
88.33 ± 2.39
70.66
NC
∧1PM2
ATM/LUM: 80/480 mg coformulated
65–75 ± 0
52–60
70–80 ± 10
56–64
NC
71.51 ± 1.60
57.21
NC
∧1PM2
ATM/LUM: 80/480 mg coformulated
<60 ± 0
<288
<60 ± 0
<288
NC
104.22 ± 2.29
500.256
C
1Q21
DHA/PPQ: 40 mg/320 mg coformulated
110–117 ± 4
44–46.8
113–120 ± 8
45.2–48
NC
124.59 ± 1.64
49.84
NC
1QM6*
DHA: 60 mg
110–115 ± 0
66–69
110–115 ± 0
66–69
BLC
106.77 ± 3.39
64.06
C
1Q22#
DHA/SDX/PYR: 60 mg/500 mg/25 mg coformulated
110–120 ± 0
66–72
107–117 ± 4
64.2–70.2
NC
—
—
—
C: compliant; NC: noncompliant; BLC: borderline compliant; has the same batch number as 1QM6*; has the same batch number as ∧1PM2. 1Q22# could not be assayed by HPLC due to interference by the sulfadoxine (SDX) component.
