Analysis method of Methylcobalamin Injection
1.0 OBJECTIVE
1.1 To lay down a procedure for Analysis of Methylcobalamin Injection.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Analysis of Methylcobalamin Injection.in QC lab
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 PROCEDURE
5.1 Identification:
5.2 Description: Pour 50ml finish sample in Beaker and observed Visually.
5.3 pH: Taken 50ml sample in beaker rinse the pH electrode first with purified water followed by sample dip the electrode in sample and observe the pH.
5.4 Volume variation: Measured the volume by syringe and determine the volume variation.
5.12 ASSAY:
Each 1.0 ml contains:
Methylcobalamin 2500 mcg.
Estimation of Methylcobalamin:
Method of Methylcobalamin:
BY HPLC
Mobile phase: 200 volume of Acetonitrile and 800 volume of 0.02 M phosphate buffer solution pH.3.5, add 3.76 gm. of sodium 1-Hexane sulphonate.
Standard preparation: weight accurately 25 mg standard weight of Methylcobalamin diluted to 100 ml volumetric flask with mobile phase. Further dilution 1.0 ml to 50 ml volumetric flask with mobile phase.
Sample preparation: Taken Accurately equivalent to 2.5mg of Methylcobalamin diluted to 100 ml volumetric flask with mobile phase.
Chromatographic condition:
Wavelength -266 nm
Column -C18 (250mm x4.6) (5.0 µm.)
Flow rate -1.0ml per minute.
Injection volume -10 µl.
Temperature – Ambient
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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