Analysis method of Levofloxacin Hemihydrate Ornidazole and Vitamin E Solution
1.1 To lay down a procedure for analysis of Levofloxacin Hemihydrate, Ornidazole &Vitamin E Solution (Vet.)
2.1 This procedure is applicable to the analysis of Levofloxacin Hemihydrate, Ornidazole &Vitamin E Solution (Vet.)
3.1 Q.C- Chemist
4.1 Manager-Quality Assurance
5.1 Description: Pour 50ml finish sample in beaker and observed visually.
5.2 pH: Taken 50 ml sample in beaker rinse the pH electrode first with purified water followed by sample dip the electrode in sample and observed the pH.
5.3 Volume variation: Measured the volume by measuring cylinder and determine the volume variation.
5.4.1 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained with the reference solution.
Each 5.0 ml contains:
Levofloxacin Hemihydrate I.P. 100 mg.
Ornidazole I.P. 200 mg.
(Alpha Tocopherol Acetate) I.P. 25 mg.
Estimation of Levofloxacin Hemihydrate, Ornidazole &Vitamin E (Alpha Tocopherol Acetate):
Method of Levofloxacin Hemihydrate& Ornidazole:
Buffer: Dissolve 1.0 ml T.E.A 500 ml of distilled water adjust to ph. 3.15 with orthophoshoric acid.
Mobile phase: Buffer : Acetonitrile
70 : 30
Standard preparation: Weight accurately about 40.0 mg. standard weight of Levofloxacin
Hemihydrate and 80.0 mg. standard weight of Ornidazole diluted to 100 ml volumetric flask with mobile phase.
Sample preparation: Taking accurately 2.0 ml Sample weight diluted to 100 ml volumetric
Flask with mobile phase.
Wavelength :315 nm.
Flow rate :1.0 ml /mint.
Injection volume :10 µl.
Column : c18 4.6X125mm 5(µm).
Retention Time of Levofloxacin Hemihydrate: 1.560 mint.
Retention Time of Ornidazole: 3.07 mint.
Method of Vitamin E (Alpha Tocopherol Acetate)
Standard Preparation: Weight accurately 25 mg. of Vitamin E (Alpha Tocopherol Acetate)
add 15 ml methanol sonicate to dissolve and make up the volume
25 ml volume flask with Methanol.
Sample Preparation: Accurately weigh sample equivalent to 25 mg of Vitamin E (Alpha
Tocopherol acetate) 15 ml methanol sonicate for 15 minute make up
The volume 25 ml volumetric flask with Methanol.
Mobile phase : Prepare a filtered and degassed mixture of methanol
Wavelength : 294 nm
Flow Rate : 1.2 ml/min
Column : C18, 4.6X250 mm 5 microns
Injection Volume : 20 µl
Diluent : methanol.
Sr. No. Abbreviation used Full form of abbreviation used
|Sr. No.||Abbreviation used||Full form of abbreviation used|
|1.0||STP||Standard Testing Procedure|
|Sr. No.||Reference Title|