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 a 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 & powder 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 injections of the standard should not be more than 2%
Procedure:
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:
Calculation:
% Assay of Lumefantrine & Artemether can be calculated by using the formula
Where,
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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