Background
Methods
Chemicals
Solutions
Background electrolyte solution
Internal standard solution
Mixed standard solution of artemether and lumefantrine
Lumefantrine test solution
Artemether test solution
Apparatus and operating conditions
Results and discussion
Method development
Selection of operation mode, electrolyte and separation conditions
Composition of the ME | Current developed, RT and migration order |
---|---|
a) 0.81% w/w octane + 6.61% w/w 1-butanol + 3.31% w/w SDS + 89.27% w/w 10 mM borate buffer | + 70 μA; RT around 12 min; MTartemether < MTlumefantrine; |
b) 0.81% w/w octane + 6.61% w/w 1-butanol + 3.31% w/w SDS + 89.27% w/w 20 mM borate buffer | + 85 μA; RT around 15 min; MTartemether < MTlumefantrine; |
c) 0.81% w/w octane + 6.61% w/w 1-butanol + 3.31% w/w LiDS + 89.27% w/w 10 mM borate buffer | + 60 μA; RT around 10 min; MTartemether < MTlumefantrine; |
d) 0.8% w/w octane + 6.6% w/w 1-butanol + 6.0% w/w SDS + 20% w/w isopropanol + 66.6% w/w 25 mM phosphate buffer | +67 μA; RT around 9 min; MTartemether > MTlumefantrine; baseline disturbance |
Selection of an extraction diluent and injection solvent for artemether and lumefantrine
Selection of an internal standard
Capillary rinse between injections
Selection of detection wavelength
Evaluation of method performances
Selectivity
Excipients | Artrine® | Coartem® | Cofantrine® | Plasmocid® |
---|---|---|---|---|
Colloidal anhydrous silica | x | |||
Hydroxypropylcellulose | x | |||
Hypromellose | x | x | ||
Isopropyl alcohol | x | |||
Lactose | x | |||
Magnesium stearate | x | x | x | x |
Methylene chloride | x | |||
Microcrystalline cellulose | x | x | x | |
Polysorbate 80 = tween 80 | x | x | ||
Sodium croscarmellose | x | x | ||
Sodium laurylsulfate sodium | x | |||
Starch | x | x | ||
Talc | x |
Linearity of the response function
Recovery studies
Exp. No. | % of the target concentration | Added amount (mg) | Found amount (mg) | Recovery (%) | Mean recovery ± RSD (%) | |
---|---|---|---|---|---|---|
Artemether
| ||||||
1 | 7.60 | 7.73 | 101.7 | |||
2 | 80 | 7.87 | 7.65 | 97.2 | 100.8 ± 3.2 | |
3 | 8.21 | 8.48 | 103.3 | |||
1 | 9.97 | 9.78 | 98.1 | |||
2 | 100 | 10.23 | 10.75 | 104.2 | 100.5 ± 3.3 | |
3 | 10.52 | 10.42 | 99.0 | |||
1 | 11.86 | 11.91 | 100.4 | |||
2 | 120 | 12.25 | 12.43 | 101.5 | 100.3 ± 1.2 | |
3 | 12.72 | 12.59 | 99.0 | |||
Lumefantrine
| ||||||
1 | 7.55 | 7.64 | 101.2 | |||
2 | 80 | 7.77 | 7.77 | 100.0 | 99.8 ± 1.4 | |
3 | 7.85 | 7.72 | 98.3 | |||
1 | 10.16 | 10.28 | 101.2 | |||
2 | 100 | 10.19 | 10.01 | 98.2 | 99.3 ± 1.7 | |
3 | 10.73 | 10.55 | 98.3 | |||
1 | 11.75 | 11.48 | 97.7 | |||
2 | 120 | 11.93 | 11.85 | 99.3 | 98.8 ± 0.9 | |
3 | 12.38 | 12.30 | 99.4 |