STP FOR FINISHED PRODUCT OF OFLOXACIN AND CEFIXIME DRY SYRUP

STP FOR FINISHED PRODUCT OF OFLOXACIN AND CEFIXIME DRY SYRUP

nirvesh400

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.

 Solvent mixture: A mixture of equal volumes of acetonitrile and water.

Test solution: After Reconstitution. Transfer powder containing 50 mg equivalent 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 mark with mobile phase. Dilute 2.0ml of this solution to 50.0 ml with solvent mixture.

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 solvent mixture.

Chromatographic system:

  • A stainless steel column 15 cm X 4.6 mm, packed with octadecylsilane bonded to porous silica (5µm), (such as Inertsil ODS-2)
  • Column temperature: 40°C
  • 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 Ornidazole in the tablets.

Formula for calculation:

             Area of Test      STD Wt.(mg)    2              100           50       Potency

—————–X————–X———X—————–X——X————-X   Average weight

Area of STD       100                50        Test Wt.(mg)    2         100

Acceptance criteria: 90.0%-110.0%

5.0)      MICROBIOLOGICAL PURITY:

            Perform the test according to requirements of IP,

Total aerobic Microbial count (TAMC): NMT 100 CFU/g

Total combined yeasts/Moulds count (TYMC): NMT 10 CFU/g

Pathogens: in 1gm of sample.

           Escherichia Coli – Should be absent

           Pseudomonas aeroginosa – Should be absent

           Salmonella – Should be absent

          Staphylococcus aureus– Should be absent

            Abbreviations:

             mg                   :Milligram

ml                    : Millilitre

Wt.                  :Weight

STD                  :Standard

HCl                  :Hydrochloric acid

inHg                 :Inch of Mercury

CFU                  :Colony forming unit

STP