Analysis method of Triclabendazole and Ivermectin Suspension
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Triclabendazole and Ivermectin Suspension
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Triclabendazole & Ivermectin Suspension in 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 obtained with the reference solution. and by chemical method.
5.5 ASSAY:
Each 1ml contains
Triclabendazole B.P. 50.0mg.
Ivermectin I.P. 1.0 mg.
Estimation of Triclabendazole and Ivermectin:
Method of Triclabendazole:
BY U.V
Methanolic HCL: 13 ml concentration HCL diluted to 300 ml methanol.
Standard Preparation: Taking weight 50 mg standard. of Triclabendazole. diluted to 100 ml Methanolic Hydrochloric acid. Further dilution 1.0 ml to 50 ml with Methanolic Hydrochloric acid.
Sample preparation: weight accurately equivalent to 50 mg. sample wt. of Triclabendazole. diluted to 100 ml with Methanolic Hydrochloric acid. Further dilution 1.0 ml to 50 ml with Methanolic Hydrochloric acid.
Weavelength-305 nm
Method of Ivermectin
BY HPLC
Mobile phase: METHANOL: WATER
90 : 10
Standard preparation: Weight accurately about 40 mg standard weight of Ivermectin diluted to 100 ml volumetric flask with mobile phase. Further dilution 10 to 50 ml with methanol.
Sample preparation: Weight accurately 8.0 gm sample weight diluted to 100 ml volumetric flask with Methanol.
Chromatographic condition:
Wavelength – 245 nm
Flow rate – 1.0 ml/mint
Injection – 10 µL.
Column- C18(4.6X125mm) 5 µm.
Retention time of Ivermectin – 9.0 mint.
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 |
7.0 (ANNEXURE)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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