Analysis method of Oxyclozanide and Fenbendazole Suspension
1.1 To lay down a procedure for analysis of Oxyclozanide and Fenbendazole Suspension.
2.1 This procedure is applicable to the analysis of Oxyclozanide and Fenbendazole Suspension. Quality control laboratory
3.1 Q.C- Chemist
4.1 Managers-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:
Oxyclozanide I.P. 150mg.
Fenbendazole I.P. 75mg.
Estimation of Oxyclozanide & Fenbendazole:
Method of Oxyclozanide:
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 150mg. std wt. of Oxyclozanide Diluted to 100 ml volumetric flask with Methanol.
Sample preparation: Weight accurately equivalent to 150 mg. Sample weight of Oxyclozanide to 100ml volumetric flask with mobile phase.
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.
Temperature – Ambient.
Method of Fenbendazole:
Mobile phase: A mixture of 350 volumes of a 0.5 per cent w/v solution of sodium dihydrogen orthophosphate and 650 volume of methanol containing 1.88 gm sodium hexanesulfonate, adjust to pH 3.5 with orthophoshoric acid.
Diluent: Equal volume of 0.1M hydrochloric acid and Methanol.
Standard Preparation: weight accurately 75 mg standard weight of Febendazole diluted to 100ml volumetric flask with diluent. further dilution 5.0 ml to 50 ml volumetric flask with diluent.
Sample preparation: weight accurately equivalent to 75 mg sample weight of Febendazole diluted to 100ml volumetric flask with diluent. further dilution 5.0 ml to 50 ml volumetric flask with diluent.
Flow rate -1.0 ml/ mint.
Injection volume -20µl.
Column -C18 25cm x 4.6mm (5µm)
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
Sr. No. Reference Title
01 In House