Analysis method of Levofloxacin Hemihydrate Ornidazole and Vitamin E Solution
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Levofloxacin Hemihydrate, Ornidazole &Vitamin E Solution (Vet.)
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Levofloxacin Hemihydrate, Ornidazole &Vitamin E Solution (Vet.)
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 PROCEDURE
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 Identification:
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.
5.5 ASSAY:
Each 5.0 ml contains:
Levofloxacin Hemihydrate I.P. 100 mg.
Ornidazole I.P. 200 mg.
Vitamin E
(Alpha Tocopherol Acetate) I.P. 25 mg.
Estimation of Levofloxacin Hemihydrate, Ornidazole &Vitamin E (Alpha Tocopherol Acetate):
Method of Levofloxacin Hemihydrate& Ornidazole:
By HPLC:
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.
Chromatographic conditions:
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.
Calculation:
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.
Chromatographic conditions:
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.
6.0 ABBREVIATIONS
Sr. No. Abbreviation used Full form of abbreviation used
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | STP | Standard Testing Procedure |
| 2.0 | QA | Quality assurance |
| 3.0 | STD | Standard |
| 4.0 | SPL | Sample |
| 5.0 | I.P. | Indian Pharmacopeia |
| 6.0 | NM | Nano meter |
7.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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