Usefulness of combined screening methods for rapid detection of falsified and/or substandard medicines in the absence of a confirmatory method

Table 2 Results from four methods for artemether/lumefantrine tablets of known quality

Drug Code	Batch	Active ingredient	Minilab		Colorimetric		CoDI		HPLC
Drug Code	Batch	Active ingredient	Error^b NMT 5%	Status (pass/fail)	Assay content (%)	Status (pass/fail)	CoDI Value	Status (pass/fail)	Assay Content (%)	Status (pass/fail)
CV^a	1	Artemether	na	Failed	0.00	Failed	0.31	Failed	0.00	Failed
CV^a	1	Lumefantrine	na	Failed	0.00	Failed	0.31	Failed	0.00	Failed
CW^a	1	Artemether	na	Failed	0.00	Failed	0.36	Failed	0.00	Failed
CW^a	1	Lumefantrine	na	Failed	0.04	Failed	0.36	Failed	0.00	Failed
CX^a	1	Artemether	0	Passed	97.71	Passed	0.48	Passed	108.17 ± 1.67	Passed
CX^a	1	Lumefantrine	0	Passed	91.42	Passed	0.48	Passed	94.09 ± 0.10	Passed
CY^a	1	Artemether	na	Failed	0.00	Failed	0.00	Failed	0.00	Failed
CY^a	1	Lumefantrine	na	Failed	0.00	Failed	0.00	Failed	0.00	Failed
CZ^a	1	Artemether	0	Passed	96.83	Passed	0.50	Passed	102.85 ± 1.18	Passed
CZ^a	1	Lumefantrine	0	Passed	84.94	Failed	0.50	Passed	90.58 ± 0.14	Passed

na: not applicable because sampling error could not be calculated due to no retardation factor (Rf) value for the test sample
^aThese samples were obtained from CDC and had previously confirmed to be of good quality, falsified or substandard
^bSampling error

ISSN: 1475-2875