Analysis method of Oxyclozanide and Levamisole Suspension
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Oxyclozanide and Levamisole Hydrochloride Suspension
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Oxyclozanide and Levamisole Hydrochloride 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.
5.5 ASSAY:
Each 1.0 ml contains:
Oxyclozanide I.P. 60 mg/30 mg.
Levamisole Hydrochloride I.P. Eq. to
Levamisole 30 mg/15mg.
Estimation of Oxyclozanide & Levamisole Hydrochloride:
Method of Oxyclozanide & Levamisole Hydrochloride:
By HPLC:
BUFFER: Dissolve 6.84gm potassium dihydrogen orthophosphate 1000 ml of distilled water adjust to ph. 3.1 with orthophoshoric acid.
MOBILE PHASE: BUFFER : METHANOL
30 : 70
Standard preparation: Weight accurately about 120mg. std wt. of Oxyclozanide and 60mg of Levamisole hydrochloride. Diluted to 100 ml volumetric flask with Methanol.
Sample preparation: Weight accurately equivalent to 120 mg. Sample weight of Oxyclozanide and 60 mg. of Levamisole hydrochloride. to 100ml volumetric flask with Methanol.
Wavelength -224nm.
Flow rate – 1.0ml per mint.
Injection volume – 20 µl.
Column – C18 (150mm x4.6) (4.0 µm.)
Retention time – Oxyclozanide about 9.5 mint.
Levamisole hydrochloride about 1.5 mint.
Temperature – Ambient.
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 (ANNEXURE)
NA
8.0 REFERENCE
Sr. No. Reference Title
01 In House
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