HPLC Method For Artemether And Lumefantrine Tablets

nirvesh400

 

 For Artemether: (By HPLC)

Test solution: Weigh and powder 20 tablets. Weight sample containing 40mg Artemether in 100ml of volumetric flask. Add 10ml of mobile phase and sonicate the sample to dissolve and makeup to the mark with mobile phase. Filter the solution and inject.

Reference solution: Weigh 20mg of Artemether reference standard in 50ml volumetric  flask. Add 10ml of mobile phase and dissolve. Sonicate the sample & shake by mechanical means for 5 min, add 40ml of mobile phase.

             Chromatographic system:

  • A stainless steel column 15cm X4.6mm, packed with octadecylsilane bonded to porous silica (5µm) (such as thermo quest hypersil), C18
  • Mobile Phase: Acetonitrile + water (60:40) and filter.
  • Flow rate: 1.2ml per minute,
  • Spectrophotometer set at 216nm,
  • Injection volume: 20µl

Inject reference solution. The test is not valid unless the relative standard deviation for replicate injections for each peak is not more than 2.0 percent.

Inject reference solution and the test solution.

Calculate the content of Artemether in the tablet.

 Formula:

Area of Test           STD Wt.(mg)              100                   Potency

—————–X——————-X——————–X—————–X   Average weight

Area of STD                 50                     Test Wt.(mg)            100

            Acceptance criteria: 90.0%-110.0%

For Lumefantrine: (By UVspectroscopy)

Reference solution: Weigh accurately about 50 mg of Lumefantrine reference standard, in 100 ml volumetric flask and dissolve in 10ml 0.1M methanolic HCl and make up the volume with 0.1M methanolic HCl. Take 1 ml of this solution in 25 ml volumetric flask and make up the volume with 0.1M methanolic HCl.

Test solution: Weigh and powder 20 tablets. Take sample equivalent to 50mg  of Lumefantrine in 100 ml volumetric flask and dissolve in 10ml  0.1M methanolic HCl, sonicate the sample and make up volume with 0.1 M methanolc HCl. Filter, and take 1 ml of this solution in 25 ml volumetric flask and make up the volume with 0.1M methanolic HCl

Scan the dilutions from 200nm to 500nm in UV spectrophotometer. The solution gives absorbance maxima at about 303nm.

  Formula:

Abs. of Test      STD Wt.(mg) 1           100                  25       Potency

—————–X————–X———X—————–X——–X———–X   Average weight

Abs. of STD        100               25     Test Wt.(mg)       1         100

            Acceptance criteria: 90.0%-110.0%

HPLC Method