analysis of Albendazole Suspension
standard testing procedure albendazole Suspension
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Albendazole Suspension.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Albendazole Suspension. in QC lab at abc pharma.
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
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 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 obtained with the reference solution.
5.5 ASSAY:
Each 5 ml contains
Albendazole I.P. 200 mg.
Releted substance: -Determine by liquid chromatography
Note; Prepare the solution immediately before use.
Solvent mixture; 30 volumes of 0.015M ammonium dihydrogen orthophosphate and 70 volumes of methanol.
Test Solution. dilute a quantity of the oral sups. Containing 500mg of Albendazole to 50.0ml with 1.0 percent w/v solution of Methanolic sulphuric acid dilute 5.0ml of this solution to 10.0ml with the solvent mixture.
Reference solution (a) Dilute 1.0ml of the test solution to 100.0ml with the solvent mixture.
Reference solution (b) Dissolve 25mg each of Albendazole RS and oxibendazole RS in 5.0ml of 1.0 percent v/v solution of Methanolic sulphuric acid and dilute to 50.0ml with solvent mixture.
Chromatographic system; a stainless steel column 25cm x4.6mm packed with octadecylsilane bonded to porous silica (5um)
Mobile phase A.0.015M ammonium dihydrogen orthophosphate in water.
Methanol; a gradient programme using the condition given flowrate 0.7ml per minute
Spectrophotometer set at 292nm
Injection volume 20ul
Resolution between two principal peak is not less than 7.0
Method of Albendazole.
Mobile phase: – A. 0.015M ammonium dihydrogen orthophosphate in water.
Diluent: – Methanolic sulphuric acid.
Standard Preparation: Taking weight 100 mg standard. of Albendazole diluted to 100 ml Methanolic sulphuric acid. Further dilution 5.0 ml to 25 ml with Methanolic sulphuric acid.
Sample preparation: weight accurately 100mg sample wt. of Albendazole. diluted to 100 ml with Methanolic sulphuric acid. Further dilution 5.0 ml to 25 ml with Methanolic sulphuric acid.
Chromatographic system: – column C18 (25cm x4.6mm) porous silica (5um)
Wavelength -292 nm
Flow rate- 0.7 ml/mint.
C18 (250 x4.6) 5 micron
Injection volume 20 µl
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6.0 ABREVIATIONS
| 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 | NM | Nano Meter |
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analysis of Albendazole Suspension