To describe Raw material testing procedure of Levofloxacin Hemihydrate.
This procedure pertains to testing of Levofloxacin Hemihydrate.
(3S)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid hemihydrate
It is the responsibility of Analyst to follow this procedure while performing testing.
It is responsibility of Supervisor to make certain that this procedure is followed in its entirety.
It is responsibility of Manager to review and make changes where applicable.
EQUIPMENTS / INSTRUMENTS:-
MATERIALS / CHEMICALS:-
Cupric Sulfate Pentahydrate
L-Isoleucine in Water
Light yellowish white to yellow white crystals or powder.
Contents are 98.0% to 102.0 %
Sparingly soluble in water, acetone and methanol.
Soluble in Dimethyl sulfoxide and acetic acid.
Practically insoluble in Glycerin and octanol.
IDENTIFICATION BY FTIR SPECTROPHOTOMETER:-
Measure the FTIR spectra of sample and compare with standard.
The Retention time of the major peak of the sample solution corresponds to the standard solution as obtained in the assay.
Preparation Of Buffer:-
8.5 mg/Litr ammonium acetate
1.25 grm/ Litr of Cupric Sulfate Pentahydrate
1.3 grm/Litr of L-Isoleucine in water
Preparation Of Mobile Phase:
Methanol and Buffer ( 3:7 )
Preparation Of Standard Solution:
Weigh 50mg of the Levofloxacin Hemihydrate RS and transfer it into 50ml of volumetric flask. Add mobile phase in it and sonicate to dissolve. Then make the volume up to the mark. Then filter the solution.
Preparation Of Sample Solution:-
Weigh 50mg of the Levofloxacin Hemihydrate (Raw Material) and transfer it into 50ml of volumetric flask. Add mobile phase in it and sonicate to dissolve. Then make the volume up to the mark. Then filter the solution.
Column : 4.6mm x 25cm x Packing L1
Detector : UV at 360nm
Column Temperature : 45°C
Flow Rate : 0.8ml/Min
Injection Size: 25µL
Calculate the Percentage of Levofloxacin Hemihydrate by using following Expression.
ru = Peak Response from the sample solution
rs = Peak Response from the standard solution
Cs = Concentration of Levofloxacin Hemihydrate in th standard solution (mg/ml)
Cu = Concentration of Levofloxacin Hemihydrate in th sample solution (mg/ml)
P= Potency of Standard
2.0% – 3.0%
50mg/ml in solvent.
92° – 106° at 20°C
United State Pharmacopeia, USP 41,NF 36, Volume III, Page No.2395-7. for Levofloxacin
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