standard testing procedure of Fexofenadine and Phenylephrine suspension
1.1 To lay down a procedure for analysis of Fexofenadine HCL and Phenylephrine HCL Suspension.
2.1 This procedure is applicable to the analysis of Fexofenadine HCL and Phenylephrine HCL Suspension in Quality control Department
3.1 Q.C- Chemist
4.1 Manager-Quality Assurance
5.1 Description: Pour 50ml finish sample in beaker and observed visually.
5.2 pH: Taken 50 ml sample in beaker rinse the pH electrode first with purified water followed by sample dip
the electrode in sample and observed the pH.
5.3 Volume variation: Measured the volume by measuring cylinder and determine the volume variation.
5.4.1 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained obtained with the reference solution.
5.5 ASSAY: –
Each 5 ml contains
Fexofenadine HCL I.P. 30 mg.
Phenylephrine HCL I.P. 2.5 mg.
Buffer: 2.5 ml Orthophoshoric acid diluted to 1000 ml water. Adjust to pH 4.8 with triethylamine.
Mobile phase: – Buffer: Acetonitrile
75 : 25
Diluent: – Water: Methanol
50 : 50
Standard preparation: Weight accurately about 30 mg standard weight of Fexofenadine in 100 ml volumetric flask with diluent and 25 mg standard weight of Phenylephrine in 100 ml volumetric flask further dilution 10 ml of phenylephrine in 100 ml volumetric flask with Diluent.
Sample preparation: Taken 5ml sample diluted in 100 ml volumetric flask with diluent.
Flow rate 1.0 ml per minute
Injection volume- 20µl.
Column- C18 250 x 4.6 mm (5 µ)
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|1.0||STP||Standard Testing Procedure|
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