Analysis method of Rafoxanide and Levamisole suspension
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Rafoxanide and Levamisole suspension.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Rafoxanide and Levamisole Suspension quality control laboratory
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 and Chemical method.
5.5 ASSAY:
Each 1 ml contains:
Rafoxanide I.P. 30 mg
Levamisole Hydrochloride I.P.
Eq. to Levamisole 30 mg
Estimation of Rafoxanide & Levamisole Suspension
Method of Rafoxanide & Levamisole Suspension:
Mobile phase: Prepare a filtered and degassed mixture of Acetonitrile and buffer in the ratio 70:30
Preparation of Buffer solution: Dissolve 5.25gms KH2PO4 and 0.525gms K2HPO4 in 1Litre of water.
Standard Preparation: Weigh accurately 30 mg of Levamisole HCL & 30 mg of Rafoxanide into a 25 ml Volumetric flask, add 15 ml of mobile phase and sonicate to dissolve and make up to the volume with mobile phase. Further mobile phase 2 ml to 25 ml with mobile phase.
Sample Preparation: Accurately weigh sample equivalent to 30 mg of Levamisole HCL & 30 mg of Rafoxanide and transfer to 25 ml volumetric flask, add 15 ml of mobile phase and sonicate for 20 minutes to dissolve and mobile phase up to the mark with mobile phase and filter the solution. Further mobile phase 2 ml to 25 ml with mobile phase.
Procedure: Separately inject equal volumes of the standard preparation and sample preparation and measure the responses of the major peaks and calculate the contents of Levamisole HCL & Rafoxanide.
Wavelength : 254 nm
Flow Rate : 1.8 ml/min
Column : C18, 250 mm x 4.6 mm, 5 microns
Inj. Volume : 20 µl
Diluent : Mobile Phase
Calculation:
6.0 ABBREVIATIONS
| 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 ATTACHMENTS (ANNEXES)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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