Method of Analysis for Levofloxacin Infusion IP (500 mg/100 ml)
PROCEDURE Levofloxacin Infusion IP
1.1 Sampling and Handling
1.1.1 Quantity of Composite Sample for Analysis
100 ml in well closed container.
1.1.2 Quantity of Reserve Sample
100 ml in well closed container.
1.1.3 Label Claim
Each 100ml Contains:
Levofloxacin Hemihydrate IP eq. to Levofloxacin….500 mg
Dextrose Anhydrous IP……5.0% w/v
Water for Injections IP……..q.s.
1.2 Test and Method
1.2.1 Description: A pale yellow colour transparent solution.
1.2.2 pH
Measure the pH value of un-diluted solution at 25°C on suitable calibrated pH meter.
Limit: Between 4.700 to 5.000
To read this method of analysis click here Method of analysis for Fluconazole Injection (200 mg/100 ml).
1.2.3 Assay:
(i) Levofloxacin (by UV)
Standard Preparation: Take 25.0 milligram of Levofloxacin hemihydrate working standard in 100.0 millilitre volumetric flask and dissolve with 0.1 M HCl than make up the volume up to 100 ml with same solvent. Further dilute 5 ml to 250 ml with 0.1 M HCl.
Test preparation: Take 5 ml of sample in 100 ml volumetric flask and dissolve with 0.1 M HCl than make up the volume up to 100 ml with same solvent. Further dilute 5 ml to 250 ml with 0.1 M HCl.
Blank solution: 0.1 M Hcl
Observe absorbance of blank, standard and sample at 292 nm and calculate amount of sample after subtracting blank solution response from both of standard and sample.
Calculation:
Sample abs / Std. abs X Std. wt / 100 X 5 / 250 X 100 / 5 X 250 / 5 X potency / 100 X 100 X 0.98 = = ———- milligram/ 100millilitre
(ii) Dextrose Anhydrous: (By Polarimeter)
Placebo Preparation:
Prepare a placebo of 1000 ml to mix all ingredients except Dextrose as per Bill of Material of Levofloxacin Infusion IP. Filter and sonicate.
Procedure:
Measure the optical rotation of the undiluted sample at 25 ºC on suitable calibrated Polarimeter. Take the blank correction by taking placebo in the Polarimeter tube at 25 ºC.
(Limit: 4.50% w/v to 5.50% w/v)
Calculation:
Calculate the content of Dextrose in % w/v by following expression:
Observed Angle of rotation X 0.9477……………………..=% w/v