VALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN FIXED COMBINED DOSAGE FORM
DOI:
https://doi.org/10.22159/ajpcr.2017.v10i3.15930Abstract
ABSTRACT
Objective: The present aim is to develop simple, precise, and accurate reverse phase high performance liquid chromatographic method (RP-HPLC) for
the simultaneous assay of artemether and lumefantrine in fixed combined dosage form.
Methods: The chromatographic study was carried out on Hypersil C18 column (250×4.6 mm, 5 μ) with mobile phase containing a mixture of KH2PO4
buffer (pH-3.5) and acetonitrile in the ratio of 45:55% v/v at a flow rate of 1.0 ml/minute with ultraviolet detection at 218 nm in ambient column
temperature.
Results: Using the optimized chromatographic conditions artemether and lumefantrine eluted with retention times of 2.207 and 3.733 minutes,
respectively. The method was validated according to ICH guidelines with good reproducibility and linear responses, y=60.813.x+629.53 (r²=0.9982)
for artemether and y=88.3108.x+2370.2 (r²=0.9912). The % relative standard deviations of intra-day precision was ranged 0.378% and 1.26% for
artemether and 0.459% and 1.15% for lumefantrine, respectively. The percentage recoveries were ranged from 99.96% to 100.02% for artemether
and 99.96-99.97% for lumefantrine, respectively.
Conclusions: The developed RP-HPLC method was validated as per ICH guidelines and was found to be best suitable for pharmacokinetic studies of
these mentioned drugs.
Keywords: Artemether, Lumefantrine, ICH guidelines.
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References
REFERENCES
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Table 6: Results of robustness studies of artemether and lumefantrine
Chromatographic parameters
Changed value
Retention time
Tailing factor
Artemether
Lumefantrine
Artemether
Lumefantrine
Flow rate (ml/minute)
8
930
907
444
308
2
780
980
368
185
Wavelength (nm)
223
710
36
219
203
207
409
219
Table 7: Stability data of artemether and lumefantrine
Drug
% Assay at 0 hr*
% Assay at 24 hrs*
% Deviation*
Artemether
40
94
99
Lumefantrine
91
98
99
*Average of six determinations
Fig. 4: Calibration curve of artemether
Fig. 5: Calibration curve of lumefantrine
Table 8: Results for analysis in formulations
Sample No. Combither
Peak area
Artemether 20 mg
Lumefantrine 120 mg
95
97
84
05
57
94
Average*
78
98
SD*
1955
0568
%RSD*
195
0568
*Average of three determinations. RSD: Relative standard deviation,
SD: Standard deviation
Asian J Pharm Clin Res, Vol 10, Issue 3, 2017, 159-163
Rao and Rambabu
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