Method of Analysis for Assay Method for Nystatin Oral Suspension

Nystatin Oral Suspension contains:

Nystatin 100000 IU / mL

Chromatographic Conditions:

Column: 250 mm × 4.6 mm, 5 µm. C18 

Flow Rate: 1.0 mL/minute 

Column Temperature: 30°C 

Detection Wavelength: 305 nm 

Injection Volume: 10 µL 

Mobile Phase : Water : Methanol : Dimethylformamide ; (15 : 70 : 15, v/v) 

Standard Solution:

Weigh accurately 20mg (equivalent to 100000 units) of Nystatin working standard and transfer into 100 mL volumetric flask add 70mL mobile phase, sonicate for 15 minutes, make up the volume with mobile phase & mix. Filter through 0.45µ filter.

Sample Preparation: Prepare Immediately before sample injection. 

Shake the container before sampling. Using a pipet, transfer a volume equivalent to 100000 units (1.0 mL) to a 100mL volumetric flask. Rinse the contents of the pipet with 10 mL mobile phase into the volumetric flask. After the mobile phase is added to bring the volume to 90 mL, sonicate for 20 min, then dilute to volume with the mobile phase. Filter through 0.45µ filter. 

Calculation: 

Calculate the amount of Nystatin: 

              Where, 

                  At - Average Area of Sample 

                  As - Average Area of Standard 

                  Ws - Weight of Standard 

                  V - Volume of Sample (mL) 

                  L – Label Claim

                  P – Potency of Standard

 

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