NEW SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF LUMEFANTRINE

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ABOUT AUTHORS:
*1Baokar Shrikrishna, 1Annadate Amol, 2Undare Santosh
1Department of Pharmaceutical Chemistry, SVPM’s College of Pharmacy, Malegaon (Bk II), Tal-Baramati, Dist- Pune, Maharashtra, India
2P.G. Department of chemistry, Balbhim arts, science and commerce college, Beed
krishnabaokar@gmail.com

ABSTRACT
A Simple, sensitive, specific, spectrophotometric method has been developed for the detection of Lumefantrine in pure and Pharmaceutical formulations. The optimum condition for the analysis of the drug was established. Lumefantrine shows maximum absorption at 228 nm and obeyed beers law in the concentration range 10 to 50 µg/ml.

The correlation coefficient was found to be 0.999 and slope of line was found to be 0.0635. The percent S.D. for intra assay precision of the method was found to be 1.85% whereas Inter assay precision was found to be 0.44%. The sample solution was stable up to 24 hours. The assay results were found to be in good agreement with label claim.

The proposed method was simple sensitive, precise, quick and useful for routine quality control.

REFERENCE ID: PHARMATUTOR-ART-2157

PharmaTutor (ISSN: 2347 - 7881)

Volume 2, Issue 5

Received On: 04/03/2014; Accepted On: 16/03/2014; Published On: 01/05/2014

How to cite this article: SK Baokar, A Annadate, S Undare; New Spectrophotometric Method Development and Validation of Lumefantrine; PharmaTutor; 2014; 2(5); 148-154

INTRODUCTION
Lumefantrine is an anti malarial drug widely used in malaria endemic areas1. Many studies have demonstrated that it is highly effective in the treatment of resistant P. falciparum malaria, resulting in high cure rates and prevention against re infection. Lumefantrine also named benflumetol and chemically (9z)-2, 7-dichloro-9-((4-chlorophenyl) methylene)-a-((dibutylamino) methyl)-9H-fluorene-4-methanol with a molecular formula C30H32Cl3NO is an aryl alcohol (shown in fig. No. 1)

FIG NO. 1 Lumefantrine

Anti malarial first synthesized in the 1970’s by the Academy of Military Medical Sciences, Beijing, China and registered in China for the treatment of malaria in 19872.The compound is a yellow powder that is poorly soluble in water, oils, and most organic solvents, but soluble in unsaturated fatty acids and acidified organic solvents. Lumefantrine is extensively bound (≈99%) to plasma proteins, mainly high density lipoproteins3. The molecular structure has been presented in fig 1. Lumefantrine as a drug is commercially available only in a fixed-dose combination with artemether4. Lumefantrine is having following side effects such as cough, diarrhea, dizziness, fatigue, headache, loss of appetite, nausea, vomiting and weakness. The exact mechanism of Lumefantrine is not well defined. Literature review reveals that the various analytical methods like HPLC-UV method (210 nm) for the simultaneous quantitation of artemether and lumefantrine in fixed doe’s combination tablets5. Liquid chromatographic method for determination of lumefantrine in capillary blood on sampling paper6 solid-phase extraction and liquid chromatographic method7 in rat plasma by liquid-liquid extraction using LC-MS/MS with electro spray ionization8,9,10,. The aim of the present work is to find out a simple, specific, sensitive, spectrophotometer method developed for the detection of Lumefantrine in pure form and in pharmaceutical formulation.

EXPERIMENTATION

Instrumentation
A double beam spectrophotometer Shimadzu UV-VIS 1700 Pharmaspec LP was used for the detection of absorbance, Afcoset FX-300 as Weighing balance and Ultra pure sonicator, borosil glass apparatus were used for experimental purpose.

Chemicals and Reagents
Lumefantrine working standard was supplied by Sequent Research Limited, Mangalore, (Karnataka-India) as a gift sample. Marketed sample for the analysis which brought from local pharmacies. Lumefantrine (100mg/tablet) was manufactured by the Shreya Pharmaceutical Pvt. Ltd. India. All other chemicals used in the analysis were AR grade.

Standard Solution
Accurately 100 mg Lumefanrine was weighed and it was diluted with 100 ml methanol. From the resulting solution 1ml was taken and made up to 100 ml to give 10ppm concentration of Lumefantrine and its absorbance was recorded.

Sample Solution
20 tablets were weighed and powdered. From this, powder equivalent to 0.379gm of Lumefanrine was taken and it was extracted with methanol and then the resulting solution is made up to 200 ml with Methanol. From the resulting solution 10 ml was taken and made up to 100 ml. then pipette out 10 ml from above solution dilute up to 100 ml with methanol, then absorbance of resulting solution was recorded

METHOD VALIDATION
Validation of the analytical method for the determination of Lumefantrine in Pure form and in pharmaceutical formulation was carried out as per ICH guidelines. All the validation parameters for Lumefantrine shown in Table No. 1

TABLE NO. 1 VALIDATION PARAMETERS FOR LUMEFANTRINE

Parameters

Lumefantrine

Measured Wavelength

228 nm

Linearity Range

10-50 ppm

Slope

0.0535

Intercept

-0.0032

Method Precision % RSD

0.1175

Correlation Coefficient

0.999

LINEARITY
The method was validated according to ICH Q2B guidelines for validation of analytical procedures in order to determine the linearity, sensitivity, precision and of the analyte11, 12, 13, 14 For Lumefantrine, five point calibration curves were generated with the appropriate volumes of the working standard solutions for UV methods. All the linearity data tabulated in Table No. 2 and linearity curve shown in Fig. No. 2

TABLE NO. 2   LINEARITY

Sr. No.

Concentration (ppm)

Absorbance

1

10

0.525

2

20

1.052

3

30

1.611

4

40

2.19

5

50

2.631


Mean

1.6018

SD

0.846625

RSD

0.5291

%RSD

52.91

Correlation coeff.

0.99915

Slope

0.0535

Intercept

-0.0032


FIG. NO. 2 LINEARITY CURVE

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