1.0) Description: Visual
2.0) Average Weight: 30 ml/9.5 gm
3.0) Identification Test:
In the assay the principal peaks in the chromatogram obtained with the test solution corresponds to the principal peaks in the chromatogram obtained with the reference solution.
4.0) Assay: Determined by liquid chromatography.
Test solution: After Reconstitution. Transfer powder containing equivalent 50 mg of Ofloxacin into 100 ml of volumetric flask. Add about 20 ml of HPLC grade methanol and sonicate for 15 minutes with occasional shaking and make up to mark with mobile phase. Dilute 2.0ml of this solution to 50.0 ml with mobile phase.
Reference solution: Weigh and transfer accurately about 50 mg of Ofloxacin reference standard and 50 mg of Cefixime reference standard into a 100 ml volumetric flask. Add about 20 ml of HPLC grade methanol and sonicate for 15 minutes with occasional shaking and make up mark with mobile phase. Dilute 2.0ml of this solution to 50.0 ml with mobile phase.
- A stainless steel column 25 cm X 4.6 mm, packed with octadecylsilane bonded to porous silica (5µm), (such as C18)
- Mobile Phase: 20 volume of buffer. And 80 volume of Methanol
- Buffer: A mixture of 4.559 g of potassium dihydrogen ortho-phosphate dissolve in 1000 ml water, adjust the Ph7.5 with O.P.A & Sodium Hydroxide.
- Flow rate: 1 ml per minute,
- Spectrophotometer set at 290 nm,
- Injection volume: 20 µl
- Column temperature: 30°
Inject the reference solution. The test is not valid unless the column efficiency for both the principal peaks is not less than 2000 theoretical plates, the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 percent.
Inject the reference solution and the test solution.
Calculate the content of Ofloxacin and Cefixime in the 5 ml contain.
Formula for calculation:
Area of Test STD Wt.(mg) 2 100 50 Potency
Area of STD 100 50 Test Wt.(mg) 2 100
Acceptance criteria: 90.0%-110.0%
ml : Millilitre
HCl :Hydrochloric acid
inHg :Inch of Mercury
CFU :Colony forming unit