J. K. Verma et al.

/ Journal of Pharmacy Research 2009, 2(9),1550-1551

Research Article
ISSN: 0974-6943 Available online through
http://jprsolutions.info
Spectrophotometric Method for Determination of
Lumefantrine in Pharmaceutical Formulations
J. K. Verma* and H. A. Syed
*Department of Chemistry, K. J. Somaiya College of Science and Commerce, Vidyavihar, Mumbai – 400077.
Received on: 22-05-2009; Accepted on:14-07-2009

ABSTRACT
A sensitive and rapid spectrophotometric method has been developed for the assay of Lumefantrine in pharmaceutical formulations. The
method is based on the absorption maximam of Lumefantrine at 234 nm and the system obeys Beer’s law in the concentration range of 2.5 –
17.5 µg/ml. The results obtained by the proposed method were validated statistically and by recovery studies.

Keywords: Lumefantrine,Spectrophotometric Method , Determination,pharmaceutical formulations.

INTRODUCTION
Lumefantrine is chemically (9Z)-2,7-Dichloro-9-[(4-chlorophenyl) me- Mefloquine, both drug combinations induced rapid clearance of para-
thylene]-a-[(dibutylamino)methyl]-9H-fluorene-4-methanol1. It is a sites and malaria symptoms; there was no significant difference in the
strong antimalerial agent used in the combination therapy with initial therapeutic response parameters. This study have been con-
Artemether. In its 2002 protocol WHO has recommended the use of ducted in Northern Laos4.
combination therapy with artemisinin derivatives in the treatment of LITERATURE SURVEY:
uncomplicated malaria due to Plasmodium falciparum. Four antima- The literature survey reveals that several methods in biological
larial drug combinations, artesunate plus amodiaquine (Arsucam®), samples for the drug have been reported5-6. No spectrophotometric
artesunate plus mefloquine (Artequin®), artemether plus lumefantrine method has been reported for the estimation of Lumefantrine in
(Coartem®; four doses and six doses), and amodiaquine plus pharmaceutical dosage forms. However, the H.P.L.C method of analy-
sulphadoxine-pyrimethamine, have been studied in five health dis- sis for the combination of Artemether and Lumefantrine is official in
tricts in Senegal2. The safety and efficacy for the use of Artemether the International Pharmacopoeia7 and for Lumefantrine the standard
and Lumefantrine have been studied in chloroquine-resistant has been developed under USP’s SALMOUS standards Guideline8.
falciparum malaria strains in Madagascar 3. The Artemether – EXPERIMENTAL:
Lumefantrine was compared with the combination of Artesunate and All spectral measurements were made on Jasco Spectrophotom-
Table 1. Assay and recovery of lumefantrine Table 2. Optical characteristics, precision and accuracy data
Dosage Labeled A *Amount found * Percentage
Form Tablet mount (mg) (mg) Percentage (%) Recovery Parameter Va l u e
A 120 121.36 101.14 100.30 λ max (nm) 234
B 120 121.22 101.02 101.51 Beer’s law limits (µg/ml) 2.5 – 17.5
C 120 120.08 100.07 100.00 Molar absorptivity (l/mol.cm) 3.8 x 104
*Each value is an average of five readings. Sandell’s sensitivity(µg/cm2/0.001 A.U) 0.91158
Correlation coefficient(r) 0.9971
Market sample of Lumefantrine in tablet dosage form: Regression equation (y)
A) Tablet Artemether - Lumefantrine B.No. 06. Slope (b) 0.0717
Label claim: Each uncoated tablet contains Artemether 20 mg and Lumefantrine Intercept (a) 0.0115
120 mg. Manufactured by: GVS Laboratories Pvt. Ltd., Mumbai.
B) Tablet Lumerax B.No. BRI 6004 R
Label claim: Each uncoated tablet contains Artemether 20 mg and Lumefantrine Table 3. Results of linearity lumefantrine at 234 nm
120 mg.Manufactured by: IPCA Laboratories Ltd., Mumbai. Stock solution Final dilution Final Absorbance
C) Tablet Lumerax B.No. BRI 7002 R (100ppm) in methanol concentration at 234 nm
Label claim: Each uncoated tablet contains Artemether 20 mg and Lumefantrine in methanol
120 mg.Manufactured by: IPCA Laboratories Ltd., Mumbai. 2.5 ml 100 ml 2.5 ppm 0.180
5 ml 100 ml 5.0 ppm 0.382
*Corresponding author. 7.5 ml 100 ml 7.5 ppm 0.553
10 ml 100 ml 10 ppm 0.735
Tel.: + 91-09867255564 12.5 ml 100 ml 12.5 ppm 0.917
E-mail:s.h.abbas@indiatimes.com 15 ml 100 ml 15 ppm 1.046
17.5 ml 100 ml 17.5 ppm 1.290

Journal of Pharmacy Research Vol.2.Issue 9.September 2009 1550-1551

 J. K. Verma et al. / Journal of Pharmacy Research 2009, 2(9),1550-1551
Fig. 1 : Linearity curve of Lumefantrine at 234 nm.
1.4
1.2
1
0.8
Abs. 0.6
0.4
0.2
0
0 5 10 15 20
Conc. in ppm
eter – V530 with a 1 cm matching quartz cell. All chemicals used REFERENCES:
were of analytical reagent grade.
A Standard solution of Lumefantrine was prepared by dissolving
12 mg of pure drug in methanol, sonicating it for 30 minutes and
diluting to 100 ml with methanol. A 5 ml aliquot of this solution
was diluted to 50 ml with methanol.
Twenty tablets were weighed and powdered. An amount of the
powder equivalent to 12 mg of the drug was weighed, transferred
into a 100 ml volumetric flask, dissolved and diluted to 100 ml with
methanol. It was sonicated for 30 minutes and filtered through
Whatman filter paper No. 41. A 5 ml aliquot of the filtrate was
pipetted out and diluted to 50 ml with methanol.
RESULTS AND DISCUSSION:
The estimation of the drug in dosage form was then carried out by
taking the reading of both standard and sample against methanol as a
blank. The absorbance of the solution was measured at 234 nm
against methanol as a blank. The drug content of the formulation and
recovery studies were conducted. The results of such studies are
Source of support: Nil, Conflict of interest: None Declared
Journal of Pharmacy Research Vol.2.Issue 9.September 2009
presented in Table 1.The proposed method of determination of
Lumefantrine shows molar absorptivity 3.8 x 104. The linear
regression of absorbance with concentration gave a correlation
coefficient of 0.9971 and RSD was found to be less than two. The
results of such studies are presented in Table 2. The proposed method
is linear over a concentration range of 2.5 µg/ml to 17.5 µg/ml. The
results are presented in Table 3. The method developed in the
present work was found to be sensitive, accurate, precise and
reproducible and can be used for routine determination of
Lumefantrine in bulk and in dosage forms.
AKNOWLEDGEMENTS:
The authors sincerely thank the Director of Padmaja Aerobiologicals
Pvt. Ltd. for providing technical support.
1. The Merck Index, 13th Edn., Merck & Co., Inc, White house station,
NJ, 2001, 1003.
2. Babakar F., Jean L. N., Daouda N., Yemou D., Oumar F. and Oumar G.,
Malaria Journal 2007, 6:80 doi:10.1186 / 1475-2875-6-80.
3. Tall A., Raharimalala L. A., Lepere J. F., Receveur M. C., Baur F.,
Rabarijaona L. P., Randrianarivelojosia M., Macarry A., Roussin C.,
Roussin J. M., Robert, V. and Ariey, F. F, Parasite, 2004 (Vol. 11) (No.
3) 325-328.
4. Stohrer J. M., Dittrich S., Thongpaseuth V., Vanisaveth
V., Phetsouvanh R., Phompida S., Monti F., Christophel E.,
Lindegardh N., Annerberg, A., and Jelinek T., Tropical Medicine &
International Health, Volume 9, Number 11, November 2004 , pp.
1175-1183 (9).
5. Annerberg A., Singtoroj T., Tipmanee P., White N. J., Day N. P. J.
and Lindegardh N., Journal of Chromatography B: Anal. Technol.
Biomed. Life Sci., 2005, 822 (1-2), 330-333.
6. Lindegardh N., Annerberg A., Blessborn D., Bergqvist Y., Day N., and
White N. J., Journal of Pharmaceutical and Biomedical Analysis, 2005,
37 (5), 1081-1088.
7. Document QAS/07.192/Final., The International Pharmacopoeia, July
2008, Dept. of Medicines Policy and Standards (PSM), World Health
Organisation, CH-1211, Geneva 27, Switzerland.
8. Authorised USP SALMOUS standard Version 1, The United States
Pharmacopeial Convention, 2009.
1550-1551