Levofloxacin Hemihydrate

PURPOSE:-

To describe Raw material testing procedure of Levofloxacin Hemihydrate.

SCOPE:-

This procedure pertains to testing of Levofloxacin Hemihydrate.

Molecular Weight:-

370.38 g/mol

Chemical Structure:-

Levofloxacin Hemihydrate
Levofloxacin Hemihydrate

IUPAC NAME:-

(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

RESPONSIBILITY:-

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:-

HPLC

FTIR

Muffle Furnace

L.O.D Apparatus

MATERIALS / CHEMICALS:-

Dimethyl sulfoxide

Acetic Acid

Distilled Water

Acetone

Methanol

Glycerin

Octanol

Cupric Sulfate Pentahydrate

L-Ammonium Acetate

L-Isoleucine in Water

Methanol 

DESCRIPTION (USP)

Light yellowish white to yellow white crystals or powder.

CONTENTS:-

Contents are 98.0% to 102.0 %

SOLUBILITY (USP)

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.

QUANTITATIVE ASSAY

PROCEDURE:-

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.

Chromatographic Conditions

Column        :           4.6mm x 25cm x Packing L1

Detector       :           UV at 360nm

Column Temperature :        45°C

Flow Rate    :           0.8ml/Min

Injection Size:          25µL

CALCULATIONS:-

Calculate the Percentage of  Levofloxacin Hemihydrate by using following Expression.

Where

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

 

L.O.D:-

2.0%  – 3.0% 

OPTICAL ROTATION:-

Solvent methanol

50mg/ml in solvent.

92° – 106° at 20°C

REFERENCE DOCUMENTS

United State Pharmacopeia, USP 41,NF 36, Volume III, Page No.2395-7. for Levofloxacin

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