Assay Method for Lumefantrine & Artemether Tablets

Each uncoated Tablets Contains
Lumefantrine 120mg 
Artemether 20mg

Chromatographic Conditions: 
Column 250 mm × 4.6 mm, C18, 5 µm 
Flow Rate 1 mL/minute 
Column Temperature 25°C 
Detection Wavelength 210nm (For Artemether), 380nm (For Lumefantrine) 
Injection Volume 20 µL 
Mobile Phase Buffer : Methanol (20 : 80, v/v) 

Buffer Preparation: 
Add 0.1ml of trifluroacetic acid, 5ml triethylamine in 200ml water and adjust the pH of solution 2.8 with orthophosphoric acid. Degas and filter the solution. 

Preparation of Acidified Methanol: 
Mix methanol and orthophosphoric acid in the ratio of 98:2 

Preparation of Standard Solutions: 
Dissolve 20mg of Artemether and 120mg of Lumefantrine working standard in 50ml of acidified methanol by sonication and dilute to 100ml with methanol. 

Preparation of Sample Solutions: 
Weigh & powdered 20 tablets. Transfer tablet powder equivalent to 120mg of Lumefantrine & 20mg of Artemether into a 100 ml volumetric flask and add 50ml of the acidified methanol, sonicate for 45minute, dilute up to the mark with methanol and filter, use the filtrate. 

System Suitability:
The % RSD for five replicate injection of standard should not be more than 2% 

Use the wavelength programming so that Artemether shall be detect at wavelength 210nm and Lumefantrine shall be detected at 380nm. Inject standard preparation in five replicate and record the chromatogram. It should comply with the system suitability criteria as mention above. Inject sample preparation in duplicate, record the chromatogram and calculate the percent of assay by using the following formula: 

% Assay of Lumefantrine & Artemether can be calculated by using the formula 
             At = Average Area of Sample solution 
             As = Average Area of Standard solution 
             Ws = Weight of Standard 
             Wt = Weight of Sample 
             ATW = Average tablet weight 
             L = Lable Claim 
             P = Potency of Standard

NOTE: Analysts have to perform Method Validation as per Regulatory Guidelines.

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