Monday, 5 July 2021

Closantel sodium Injection Assay (By HPLC) Finished Product | Test Procedure | Method of analysis (MOA) |



Closantel sodium Injection Assay (MOA) By HPLC


Chromatographic Conditions :

Column                        -  C18( 50 x 4.6mm ) 5μm or equivalent

Detector wavelength - 240 nm

Flow Rate                      - 1.0 ml / Minute

Injection volume          - 10 μl.

Retention time               - About 16.0 min

Diluent and wash vial  - Methanol  

 

Buffer Preparation:

Dissolve 7.7 gm ammonium acetate in 1000 ml of water adjusted to pH 4.3 with acetic acid.

Filter with 0.45µm nylon membrane filter.

Gradient Progamme:

Time

Mobile Phase A

Mobile Phase B

0

50

50

2

50

50

22

20

80

27

20

80

30

50

50

35

50

50

 

Standard Preparation

Accurately weigh and transfer about 52.0 mg of Closantel sodium Dihydrate WS in 100 ml volumetric flask and add about 70 ml of diluent, Sonicate to dissolve and make up the volume 100 ml with diluent.

Dilute 5 ml of this solution to 50 ml with diluent and mix.

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\Sample Preparation

Weigh and transfer sample solution i.e. equivalent to 100 mg of Closantel in 100 ml volumetric flask, add about 70 of diluent, sonicate for 10 min with intermittent shaking in every after 2 min and make up the volume 100 ml with diluent.

Dilute 5 ml of this solution to 100 ml with diluent and mix. Filter with 0.45µ nylon syringe filter.

Procedure:

Inject one blank, five replicate injection of standard solution, two replicate injection of sample solution & two bracketing standard solution.

System Suitability :

1) RSD of five replicate injection of standard solution should  not be more than 2.0%

 2) RSD of five replicate injection of  standard solution and  two bracketing  standard solution should not be more than  5.0%

 3) Tailing factor should not be more than 2.0 and Theoretical plates should not be less than 2000.

 Calculation :