standard test procedure ofloxacin and ornidazole infusion

Product Name : STANDARD TEST PROCEDURE OFLOXACIN AND ORNIDAZOLE INFUSION
Label Claim : 200mg Ofloxacin 500mg Ornidazole

1. PROCEDURE
1.1 Ofloxacin Infusion : Ofloxacin and ornidazole Infusion is a sterile solution of Ofloxacin ornidazole Infusion contains not less than 90.0 per cent

and not more than 120.0 per cent of the stated amount of ofloxacin,and ornidazole.
1.2 Usual strengths.
1.2.1 200mg Ofloxacin 500mg Ornidazole
1.3 Identification
1.3.1 In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution.
1.4 pH
1.4.1 3.8 to 7.5.
1.5 Other tests.
1.5.1 Comply with the tests stated under Parenteral Preparation (Infusions).
1.6 Assay.
1.6.1 Ofloxacin Determine by liquid chromatography NOTE -Protect the solutions from the light. Test solution. Measure a volume containing 50 mg of

Ofloxacin in 100.0 ml with mobile phase. Dilute 5.0 ml of the solution to 50.0 ml with mobile phase. Reference solution. A 0.005 per cent w/v solution

of ofloxacin RS in mobile phase. Chromatographic system – a stainless steel column 25 cm x 4.6 mm packed with octadecylsilane bonded to

porous silica (5 tun), – mobile phase: a mixture of 80 volumes of buffer solution prepared by dissolving 6.8 g of potassium dihydrogen

orthophosphate and 0.47 g sodium 1-hexane sulphonate in 1000 ml of water, add 1 ml of triethylamine sulphate and 3.56 g of disodium

hydrogen phosphate in 1000 ml water – flow rate: 1.5 ml per minute, – spectrophotometer set at 294 nm, – injection volume: 20 pl. Inject the reference solution.

The test is not valid unless the relative standard deviation for replicate injections is not more than 2.0 per cent. Inject the reference solution and the test solution.

Calculate the content of ofloxacin
1.6.2 Assay. Ornidazole Determine by liquid chromatography Solvent mixture. 50 volumes of methanol and 50 volumes of water. Test solution.

Dilute a volume of injection with the solvent mixture to obtain a solution containing 0.0033 per cent w/v of Ornidazole. Reference solution.

A 0.0033 per cent w/v solution of ornidazole RS in the solvent mixture. Chromatographic system – a stainless steel column 15 cm x 4.6 mm, packed with

octadecylsilane bonded to porous silica (5 pm), – mobile phase: a mixture of 90 volumes of a 0.136 per cent w/v solution of potassium dihydrogen

orthophosphate in water, adjusted to pH 3.0 with orthophosphoric acid and 10 volumes of acetonitrile, – flow rate: 2 ml per minute, – spectrophotometer

set at 300 nm, – injection volume: 20 pl. Inject the reference solution. The test is not valid unless the column efficiency is not less than 2000 theoretical plates,

the tailing factor is not more than 2.0 and the relative standard deviation is not more than 2.0 per cent. Inject the reference solution and the test solution.

STP NO.	REASON FOR CHANGE	REVISION NUMBER	CHANGE CONTROL NUMBER	EFFECTIVE DATE
	New STP	00	NA

standard test procedure ofloxacin and ornidazole infusion

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