Monday 9 October 2017

Lumefantrine Tablets (Assay) (By HPLC) | Finished Product | Test Procedure | Method of analysis (MOA) |












By HPLC

Column: C18 octadecylsiiyl silica gel (25 cm x 4.6 mm)

Wavelength: 235 nm

Injection volume: 20 µl

Flow rate: 1.0 ml/min

Solution preparation:

Mobile phase:  Prepare a mixture of 750 volumes of Acetonitrile, 250 volumes of water and 10 volumes of triethylamine, adjust the pH to 3.0 with orthophosphoric acid, filter and degas.

Diluent:  Ethanol

Blank solution:  Diluent

Standard solution:
Weigh accurately about 120.0 mg of Lumefantrine working standard and transfer to a 100 ml volumetric flask, add 50 ml of diluent, sonicate to dissolve and dilute to volume with diluent.
Further transfer 5.0ml of above solution to 50 ml volumetric flask and dilute to volume with diluent. (120 mcg/ml)

Test solution:
Transfer an amount of finely powdered tablets (powder not less than 20 tablets), equivalent to 120.0 mg of lumefantrine to a 100 ml volumetric flask. Add 50 ml of diluent, sonicate for 15 minutes and dilute upto the mark with diluent, mix and filter the solution through whatman filter paper.
Further transfer 5.0 ml of the filtrate into a 50 ml volumetric flask and dilute upto the mark with diluent. (120 mcg/ml)

Procedure:
Separately inject blank solution one time, standard solution six times and test solution two times into the chromatograph. Record the peak responses and evaluate statistically.

% RSD standard solution in not more than 2.0%.


Calculation: