| Method of analysis for Fluconazole Injection (200 mg/100 ml) |
| 1.0 PROCEDURE 1.1 Sampling and Handling of Fluconazole Injection 1.1.1 Quantity of Composite Sample for Analysis 100 ml in well closed container 1.1.2 Quantity of Reserve Sample of Fluconazole Injection 100 ml in well closed container 1.1.3 Label Claim Each 100ml contains : Fluconazole IP………..….200 mg Sodium Chloride IP………0.9% w/v Water for Injections ……..q.s. To read this Method of analysis click here Method of Analysis for Sodium Chloride Injection IP (0.9% w/v). 1.2 Test and Method 1.2.1 Description: A clear colourless solution. 1.2.2 pH Measure the pH value of un-diluted soln. at 25°C on suitable calibrated pH meter. Limit: 4.5 to 5.5 1.2.3 Assay: (i) Fluconazole (By UV) Standard Preparation: Take 50 mg of fluconazole working standard in 50 ml volumetric flask and dissolve with methanol than make up the volume up to 50 ml with same solvent. Further dilute 10 ml to 50 ml with methanol. Test preparation: Take 5 ml of sample in 50 ml volumetric flask and dissolve methanol than make up the volume up to 100 ml with same solvent. Use methanol as a blank. Measure absorbance of blank, standard and sample at 261 nm and calculate amount of sample after subtracting blank solution response from both of standard and sample. Calculation: Sample abs / Std. abs X Std. wt / 50 X 10 / 50 X 50 / 5 X Potency / 100 X 100 = …….mg/100 ml % Assay = …….mg/100 ml / Label claim X 100 (ii) Sodium Chloride: (By Titration method) Take 10 ml of test sample in 250 ml of conical flask; add 0.5 ml of 5 % w/v solution of Potassium Chromate and 50 ml of distilled water and titrate with 0.1 M Silver Nitrate volumetric solution until the color of solution becomes reddish yellow. Each ml of 0.1 M Silver Nitrate is equivalent to 0.005844 g of Sodium Chloride. Calculation: Volume consumed of 0.1M AgNO3 X 0.005844 X Actual Molarity of AgNO3 X 100 / 10.0 X 0.1 = …………% w/v |
