VALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN FIXED COMBINED DOSAGE FORM


Payyavula Venkata Rao, Rambabu C

Abstract


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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ICH Harmonized Tripartite Guideline International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text and Methodolgy; 2005.




About this article

Title

VALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN FIXED COMBINED DOSAGE FORM

DOI

10.22159/ajpcr.2017.v10i3.15930

Date

01-03-2017

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Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 10 Issue 3 March 2017 Page: 159-163

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

115 Views | 136 Downloads

Authors & Affiliations

Payyavula Venkata Rao

Rambabu C


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