- Description: Visual
- Identification: To be confirmed by assay.
- Uniformity of volume:
Pour completely the contents of each container into calibrated measuring cylinder of the appropriate size and determine the volume of the contents of the 10 containers.
The average net volume of the contents of the 10 containers is not less than the labeled amount, and the net volume of the contents of any single containers is not less than 91% and not more than 109% of the labeled amount where the labeled amount is 50 ml or less, or not less than 95.5% and not more than 104.5% of the labeled amount where the labeled amount is more than 50 ml but not more than 200 ml, or not less than 97% and not more than 103% of the labeled amount where the labeled amount is more than 200 ml but not more than 300 ml.
- pH : Limits :(3.5 to 5.5)
Check that the pH meter is calibrated, if not calibrate it with buffer solution 7.0, 4.0 and 9.2 Take out the electrode and wash it with distilled water and clean it with tissue paper. Take the sample into 100 ml dried and clean beaker and put the electrode into the solution wait for 2 min for stable reading on the LCD of the pH meter. Note down the reading of pH value and clean the electrode with distilled water and dried it with tissue paper and place the electrode in the storage solution.
- Content of active ingredients: Each 5 ml contains
Assay By HPLC
For Bromhexine Hcl IP 2mg Limit: 1.8 mg to 2.2mg
Guaiphenesin I.P 50mg Limit: 45.0mg to 55.0mg
Terbutaline sulphate I.P 1.25mg Limit: 1.125mg to 1.375mg
- Assay For Guaiphenesin and Terbutaline Sulphate
Column : C18, 250 mm x 4.6 mm, 5 µ.
Wave length : 215 nm
Flow rate : 1.5 ml/ min
Injection volume : 20 µl
Diluent : Mobile phase
Mobile Phase : Buffer: Methanol (450: 550)
Buffer preparation : 1.56 gm NaH2PO4 in 1000ml water. Adjust pH 2.0 ± 0.05 with phosphoric acid.
Take the 62.5 mg Terbutaline Sulphate in 50 ml volumetric flask make up the volume up to the mark with mobile phase. Sonicate for 10 minutes for compete dissolution. Take 5.0 ml of this solution and dilute to 200 ml by adding 50 mg of Guaiphenesin Standard and make up the volume with mobile phase.Sonicate for 10 minutes. Filter the solution and make the vial.
Dilute a volume of the liquid containing about 50 mg of Guaiphenesin, 1.25 mg Terbutaline sulphate in 200.0ml volumentric flask add 5ml methanol sonicate for 10 minutes and make up with the mobile phase.
Ist peak Indicates : Terbutaline sulphate.
IInd peak Indicates : Guaiphenesin.
Calculation for Guaiphenesin:
Sample Area X Std wt X 200 X P X 5
Std Area 200 5 100
For Terbutaline sulphate:
Sample Area X Std wt X 10 X 200 X P X 5
Std Area 50 200 5 100
Assay For Bromhexine Hcl 2mg:
Working Standard: 50mcg/ml in 0.1M Hydrochloric acid
About 50mg of Bromhexine Working Standard in 100 ml Volumetric. Flask. Add 20 ml 0.1 M Hydrochloric acid. Sonicate for 10 min. make up to mark with 0.1M Hydrochloric acid.
5 ml of above solution in 50 ml volumetric flask. Make to mark with 0.1M Hydrochloric acid,
12 ml (About 5mg) of sample in 250ml Separating funnel add 10 ml water. Basify with dilute ammonia solution. And extract with n-Hexane (4 x 25 ml). Combine the organic layer and extract with 0.1M Hydrochloric acid. Use acidic layer and dilute to 100ml with 0.1M Hydrochloric acid
Measure the Absorbance of both sample and standard solution at 317 nm.
Sample Area X Std wt X 5 X 100 X P X 5
Std Area 100 50 12 100