Development of the RP-HPLC Method for Simultaneous Determination and Quantification of Artemether and Lumefantrine in Fixed-Dose Combination Pharmaceutical Dosage Forms
Table 7
Results of analyses of market samples using the developed RP-HPLC method.
Formulation
Sample code
Retention time L/A (min)
Percentage content of artemether (%)SD
ΨPercentage content of lumefantrine (%)SD
Remarks on API content
Tablet
LZT
1.44/5.38
97.761.03
91.811.14
Passed
LNT
1.41/5.38
99.680.89
97.551.05
Passed
MLT
1.39/5.36
99.500.23
98.331.23
Passed
LFT
1.40/5.38
99.490.18
96.830.28
Passed
CTT
1.41/5.37
99.890.76
99.120.97
Passed
TMT
1.39/5.38
96.900.25
91.641.11
Passed
IDT
1.40/5.38
94.940.06
92.161.26
Passed
DMT
1.39/5.38
99.680.34
96.520.73
Passed
Suspension
MLS
1.42/5.30
98.370.54
99.710.27
Passed
LFS
1.42/5.40
99.920.32
97.981.09
Passed
IDS
1.42/5.40
100.100.25
91.271.16
Passed
LNS
1.42/5.43
98.500.88
97.721.02
Passed
STS
1.42/5.42
116.760.94
80.351.01
Failed
BMS
1.42/5.43
88.310.44
82.080.98
Failed
L = lumefantrine. A = artemether. Acceptance criteria (BP): 90%–110%. ΨAcceptance criteria (BP): 90%–110%.
