Analysis method of Torsemide Injection
1.0 OBJECTIVE
1.1 To lay down a procedure for Analysis of Torsemide Injection.
2.0 SCOPE
2.1 This procedure is applicable to the Analysis of Torsemide Injection. in Quality control
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Head-Quality Assurance
5.0 Identification: In the assay the principal peak in the chromatogram obtained with the test solution corresponds to the peak in
the chromatogram obtained with the reference solution.
6.0 Description: Pour 10ml finish sample in Beaker and observed Visually.
7.0 pH: Taken 40ml sample in beaker the pH electrode first with purified water followed by sample dip the electrode in sample and observe the pH.
8.0 Extractable volume: Measured the volume by 10 ml Measuring cylinder and determine the volume.
9.0 Particulate matter: Injections that are solutions, when examine under suitable conditions of visibility are clear and
practically free from particles that can be observed on visual inspection by the unaided eye.
10.0Sterility: – Injection comply with the test for sterility as per SOP
11.0 Bacterial endotoxins: –
Injection comply with the test of Bacterial endotoxin as per SOP
12.0 Composition: –
Each ml contains:
Torsemide USP 10 mg.
14.0 Assay: – NLT 90.0% and NMT 110.0%
Method of Torsemide: – Determine by liquid chromatography.
Buffer: Dissolve in 0.02 M Phosphate buffer in water adjust to pH 3.5 with Orthophoshoric acid.
Mobile phase: – Methanol: Water
50 : 50
Standard preparation: -Weight accurately about 30 mg working standard of Torsemide add 50 ml methanol mix and sonicate to dissolve.
And diluted to 100 ml of mobile phase phase.
Sample preparation: -Take sample equivalent about 30 mg working standard of Torsemide add 50 ml methanol mix and sonicate to dissolve.
And diuted to 100 ml of mobile phase.
Chromatographic condition: – Wavelength-288 nm
Flow rate 1.5 ml per minute
Injection volume- 20 µl.
Column- C18 15cm x 4.6 mm (5 µm)
Record the Chromatogram and measure the peak response of the measure peaks. Calculate the content of Torsemide Respectively.
Calculation: –
Area of spl Wt. of std
………………… X……………………. X 100 X % Potency of Standard X 1
Area of std Wt. of spl
Procedure: – Inject Blank in single injection, Standard preparation in Replicates of three, test preparation in duplicate injection.
System suitability: – % RSD of three replicate injections should not be more than 2.0.
15.0 ABBREVIATION: –
| 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 |
16.0 REFERENCE: –
| Sr. No. | Reference Title |
| 01 | IHS |
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