Analysis of Ranitidine injection

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3 years ago

Analysis of Ranitidine injection

1.0 OBJECTIVE
1.1 To lay down a procedure for Analysis of Ranitidine injection.

2.0 SCOPE
2.1 This procedure is applicable to the Analysis of Ranitidine injection. (1ml) in QC lab

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: –
NMT 7.0 Endotoxins unit/mg of Ranitidine as per SOP

12.0 Related substance: Determine by liquid chromatography.
Test solution: -Dilute a volume of the injection with water to obtain 0.1 per cent w/v of Ranitidine.
Reference solution (a) Dilute 1.0 ml of the test solution to 50.0 ml with water.

Reference solution (b) Dilute 1.0 ml of the test solution to 100.0 ml with water.

Reference solution (c) Dilute 1.0 ml of the test solution to 200.0 ml with water.

Reference solution (d) Dilute 1.0 ml of reference (b) to 5.0 ml with water.

Reference solution (e) Dissolve the content of a vial of Ranitidine impurity J RS in 1.0 ml of a 0.013 percent w/v solution of ranitidine hydrochloride RS in water.

Buffer: – 0.05M potassium dihydrogen phosphate. 1000 ml water. adjust to pH 7.1
With Sodium hydroxide.

Mobile phase (A): – A mixture 2 volume of acetonitrile and 98 volume of Buffer.

Mobile phase (B): – A mixture 22 volume of acetonitrile and 78 volume of Buffer.

Chromatographic condition: – Wavelength-230 nm
Flow rate 1.5 ml /mint.
Injection volume- 20 µl.
Column- C18 10cm x 4.6 mm (3.5µm)

A gradient programme using the condition below

Time Mobile phase A Mobile phase B

(in min) ( percent v/v) ( percent v/v)

0 100 0

10 0 100

15 0 100

16 100 0

20 100 0

Inject reference solution(e) the test is not valid unless the resolution between two principal peak is not less than 1.5
Inject reference solution(a), (b), (c), (d) and the test solution in the chromatogram obtained with the test solution the area of any secondary peak is not more than the principal peak in the chromatogram obtained with the reference solution (a) (2.0 percent). The area of not more than one secondary peak is more than the area of principal peak in the chromatogram obtain with the reference solution (b) (1.0 percent) The area of not more than two other secondary peak is more than the area of principal peak in the chromatogram obtained with reference solution (c) (0.5 percent) and the area of not more than two further secondary peak is more than the area of principal peak in the chromatogram obtained with reference solution (d) (0.2 percent).

13.0 Composition: –
Each ml contains:
Ranitidine HCL I.P.
Eq. to Ranitidine 25.0 mg.

14.0 Assay: – NLT 90.0% and NMT 110.0%
Method of Ranitidine: – Determine by liquid chromatography.
Mobile phase: a mixture of 85 volumes of methanol and 15 volumes of 0.1 M ammonium acetate, (7.70 gm ammonium acetate produced to 1000 ml water.)

Standard preparation: Weight accurately about 25 mg std wt. of Ranitidine in 100 ml of mobile phase. Further dilution 10 ml to 25 ml with mobile phase.

Sample preparation: Weight accurately equivalent to 25 mg std wt. of Ranitidine in 100 ml of mobile phase. Further dilution 10 ml to 25 ml with mobile phase.

Chromatographic condition: Wavelength-322 nm
Flow rate 2.0 ml /mint.
Injection volume- 20 micro liter.
Column- C18 (25cm x 4.0 mm) (5 micron)

Record the Chromatogram and measure the peak response of the measure peaks. Calculate the content of Ranitidine 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