Standard Testing Procedure Drotaverine Hydrochloride injection

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

2.0 SCOPE
2.1 This procedure is applicable to the Analysis of Drotaverine Hydrochloride.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 in syringe or 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 0.25 Endotoxins unit/mg of Ondansetron as per SOP
12.0 Composition: –
Composition:
Each ml contains:
Drotaverine Hydrochloride I.P. 20 mg.
Benzyl Alcohol I.P. 2% v/v
(As preservative)
13.0 Assay: – Drotaverine Hydrochloride Limit: – NLT 90.0% and NMT 110.0%
Buffer: 21.80 gm Sodium acetate 500 ml water. 60 ml glacial acetic acid dilute to 1000ml with water.
Mobile phase: 440 ml buffer + 480 ml Acetonitrile +80 ml Methanol

Standard preparation: Weight accurately about 20 mg Working standard. of Drotaverine in 100 ml with mobile phase.
Sample preparation: Take sample equivalent to 20 mg of Drotaverine 100 ml with mobile phase.
Chromatographic condition:
Wavelength-254 nm
Flow rate 1.0 ml /mint.
Injection volume- 20 µl.
Column- C18 250 x 4.6 mm bonded to porous silica 5µm.

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

Respectively. Retention time of the Principal peak is about 6.0 Minutes.

Calculation: –

Area of spl Wt. of std

…………… x …………… X 100X % 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.

14.0Assay: – Limit: -NLT 90.0 % & NMT 110.0%

Method of Benzyl Alcohol: –
Buffer: – 28.4 g of Sodium sulphate dilute in 1000ml water adjusted to pH 2.3 with Orthophoshoric Acid.

Mobile phase: – Buffer: Acetonitrile
55 : 45

Standard preparation: -Weight accurately 500 mg Working standard of Benzyl Alcohol in 100 ml volumetric flask with water.

Further dilution 1 ml to 100 ml volumetric flask with water. (concentration 50 ppm)

Sample preparation: – Take sample accurately equivalent to500 mg Benzyl Alcohol Working standard diluted to 100 ml volumetric

flask with water. Further dilution 1 ml to 100 ml volumetric flask with water. (concentration 50 ppm)

Chromatographic condition: –
Wavelength- 214 nm
Flow rate- 1.0 ml /mint.
column c18 (250 x4.6) bonded to porous silica 5µm.
Retention time: 9.0 to 10.0 mint
Injection Volume: 20µl
Column temp. 400C
Run time: – 30.0 minutes.
Record the Chromatogram and measure the peak response of the measure peaks. Calculate the content of Benzyl Alcohol Respectively.