Description: Orange colored viscous flavored suspension.
Observation:………………………………………………………. (Complies/Not Complies)
pH:……………………….. (Complies/Not Complies)
Identification:
- Ofloxacin: In the assay, the principle peak in the chromatogram obtained with the test solution corresponds to that in chromatogram obtained with the reference solution. (Complies/Not complies)
- Metronidazole : In the assay, the principle peak in the chromatogram obtained with the test solution corresponds to that in chromatogram obtained with the reference solution.
(Complies/Not complies)
Assay:Each 5ml contains: Ofloxacin IP 50mg & Metronidazole IP 100mg
Mobile phase preparation:-[Buffer:3.4gm KH2PO4→500 ml HPLC water and adjust pH 3.5]
[Mobile phase:600 ml Acetonitrile :400 ml buffer]
Wavelength: 313 nm
Column: 150 mm
Temp. 30 deg.
Procedure:
Working standard dilution:25mg Ofloxacin+50mg Metronidazole→100ml M.P→2ml→25ml M.P.
Sample dilution: 2.5gm →100ml M.P.→Sonicate→Filter→2ml→25ml M.P.
Formula:
Area of Test STD Wt.(mg) 2 100 25 Potency
——————–X—————-X——–X————–X———X———X ml contains .
Area of STD 100 25 Test Wt.(mg) 2 100
Calculation:
Weight of Test: Weight of STD :
Ofloxacin:
Metronidazole:
Area of Test: Area of STD :
Ofloxacin : Ofloxacin:
Metronidazole: Metronidazole:
2 100 25 P
Ofloxacin ————————-X————X——–X———X——— X———X 2
100 25 2 100
= /50X100 = %
2 100 25 62
Metronidazole ——————–X————X——–X———X——— X———X 5
100 25 2 100
= /100X100 = %
