Development of the RP-HPLC Method for Simultaneous Determination and Quantification of Artemether and Lumefantrine in Fixed-Dose Combination Pharmaceutical Dosage Forms

Table 1

System suitability data for artemether and lumefantrine.

API	Injection	Retention time/min	Peak area/mAU	Symmetry factor	Theoretical plates
Artemether	1	5.38	250.243	0.91	2305
	2	5.38	249.452	0.90	2289
	3	5.37	251.245	0.91	2325
	4	5.38	250.365	0.91	2297
	5	5.37	250.054	0.90	2287
	6	5.38	251.144	0.91	2280
	Mean	5.377	250.417	0.91	2297.17
	SD	0.0047	0.6205	0.0052	16.1297
	% RSD	0.088	0.248	0.570	0.702
Lumefantrine	1	1.42	9466.254	1.31	5078
	2	1.42	9457.814	1.32	5019
	3	1.41	9472.300	1.31	4987
	4	1.42	9454.223	1.32	5100
	5	1.42	9447.235	1.32	5018
	6	1.42	9454.890	1.32	5009
	Mean	1.418	9458.786	1.32	5035.167
	SD	0.004	9.0418	0.0052	43.8151
	% RSD	0.29	0.10	0.39	0.87

Acceptance criteria: RSD ≤ 2%, tailing factor ≤2, theoretical plates ≥2000, and resolution (R) ≥2.