Each uncoated Tablets Contains
Lumefantrine 120mg
Artemether 20mg
Dissolution of Artemether
Dissolution Condition:
Medium : Water ; 1000 mL.
Apparatus : II ( Paddle )
Speed : 100 RPM
Time : 60 min
Temperature : 37°C ± 0.5°C
Standard Solution:
Transfer 40mg of Artemether working standard into a 200 ml volumetric flask and add 100 ml of the diluent, sonicate to dissolve dilute up to the mark with diluent. Dilute 5ml of this solution to 50ml with dissolution media.
Sample Solution:
Place 1000mL of dissolution medium maintained at 37±0.5°C in 6 dissolution vessels separately & fix in the tablet dissolution bath. fix the paddle to the shaft & bring it into position. Place 1 tablet each into 6 dissolution vessels. Operate the instrument at 100 RPM for 60 min. At the end of 60 min, withdraw 5mL of a sample, Filter through 0.45µ filter and fill the vial.
Chromatographic Conditions:
Column : 125 mm × 4 mm, C18, 5 µm
Flow Rate: 1 mL/minute
Column Temperature: 25°C
Detection Wavelength: 210 nm
Injection Volume: 50 µL
Mobile Phase:
Mix 500ml of Acetonitrile, 400ml of water, 100ml of 1-Propanol and 1ml trifluoroacetic acid degas and filter the mixture.
Diluent: Mix water and Acetonitrile in the ratio of 1:1
System suitability:
The % RSD for five replicate injection of standard preparation should not be more than 2%
Procedure:
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 single for each Bowl, record the chromatogram and calculate the % dissolve by using the following formula:
Where,
At = Area of Sample
As = Average Area of Standard
Ws = Weight standard
L = Label claim
V = Volume of medium
P = Potency of standard
Dissolution of Lumefantrine
Dissolution Condition:
Medium : 0.1N HCL containing 1% Benzalkonium Chloride ; 1000 mL.
Apparatus : II ( Paddle )
Speed : 100 RPM
Time : 45 min
Temperature : 37°C ± 0.5°C
Preparation of 0.1M HCL containing 1% Benzalkonium Chloride:
Dissolve 85ml of Hydrochloric acid and 200ml Benzalkonium Chloride (50%) in 10L of water.
Preparation of Acidified Acetonitrile: Mixed Acetonitrile: Acetic Acid (98: 2, v/v)
Preparation of Standard Solution:
Transfer 120 mg of Lumefantrine working standard into a 100 ml volumetric flask and added 80ml of the acidified acetonitrile, sonicate to dissolve dilute up to the mark with same. Diluted 5ml of this solution to 50ml with dissolution media. Again dilute 5ml of diluted solution to 25ml with dissolution medium.
Sample Solution:
Place 1000mL of dissolution medium maintained at 37±0.5°C in 6 dissolution vessels separately & fix in the tablet dissolution bath. fix the paddle to the shaft & bring it into position. Place 1 tablet each into 6 dissolution vessels. Operate the instrument at 100 RPM for 45 min. At the end of 45 min, Withdraw 10ml from each vessel, filter and dilute 5ml of the filtrate to 25ml with dissolution media.
Measure the absorbance of the standard and sample solution, at wavelength 342 nm.
Calculation:
Calculate the % Dissolution of Lumefantrine by using the formula:
Where,
At = Absorbance of Sample
As = Average Absorbance of Standard
Ws = Weight standard
L = Label claim
V = Volume of medium
P = Potency of standard
NOTE: Analysts have to perform Method Validation as per Regulatory Guidelines.
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