MICROBIOLOGICAL ASSAY FOR THE DETERMINATION OF CEFPIROME IN RAW MATERIAL AND INJECTABLE PREPARATION

Cefpirome is a fourth-generation cephalosporin active against a broad spectrum of gram-negative and gram-positive bacterial infections. The present work describe the development and validation of a simple, sensitive and specific agar diffusion bioassay applying cylinder-plate method for quantification of cefpirome in raw material and powder for injectable preparation. The validation method yielded good results and included linearity, precision, accuracy and specificity. The assay is based on the inhibitory effect of cefpirome upon the strain of Kocuria rizophila ATCC 9341 as the test microorganism. The result of assay were treated statistically by ANOVA and the response graphs for standard and sample solutions were linear (r = 0.9948) in the range of 0.3 – 1.2 µg mL-1, precise (intra-assay: RSD = 0.11; inter-assay: RSD = 0.18) and accurate (mean recovery value = 99.41%). A preliminary stability study of cefpirome showed that the microbiological assay is specific for the determination cefpirome in the presence of its degradation products. The proposed microbiological method allows the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRY AND LIQUID CHROMATOGRAPHY METHODS FOR DETERMINATION OF CEFPIROME IN RAW MATERIAL AND PHARMACEUTICAL DOSAGE

In the present work, analytical methods, UV Spectrophotometry and Liquid Chromatography (HPLC), were developed and validated for quantification of cefpirome, a broad-spectrum fourth-generation cephalosporin, in raw material and powder for injectable preparation. The UV spectrophotometric method was performed at 271 nm, using 0.1 M hydrochloric acid as solvent. The HPLC was carried out using Techsphere ODS column and mobile phase consisted of methanol-water (30:70, v/v) with flow rate 0.8 mL/min and UV detection at 265 nm. The validation method yielded good results demonstrated statistically that the methods were linear, precise, accurate, specific and robust. A preliminary stability study of cefpirome showed that the UV Spectrophotometry and Liquid Chromatography methods were specific for the determination cefpirome in the presence of its degradation products. No statistically difference was observed between the proposed methods. The UV Spectrophotometry and Liquid Chromatography methods allow the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control.

LC method for quantitative determination of Ciprofloxacin in ophthalmic ointment

The objective of the study was to validate an analytical method for the quantification of ciprofloxacin in ophthalmic ointment by high performance liquid chromatography. The chromatographic separation of ciprofloxacin hydrochloride was achieved on a Thermo hypersil Gold C18 column using UV detection at 278 nm. The optimized mobile phase consisted of a mixture of 0.025 M phosphoric acid with a pH previously adjusted with triethylamine to 3.0 and acetonitrile (85:15, v / v). The validation method yielded good results demonstrated statistically that the method was linear, precise, accurate, specific and robust. No interference from any components of the pharmaceutical dosage forms was observed.

LC method for quantitative determination of Ciprofloxacin in ophthalmic ointment

The objective of the study was to validate an analytical method for the quantification of ciprofloxacin in ophthalmic ointment by high performance liquid chromatography. The chromatographic separation of ciprofloxacin hydrochloride was achieved on a Thermo hypersil Gold C18 column using UV detection at 278 nm. The optimized mobile phase consisted of a mixture of 0.025 M phosphoric acid with a pH previously adjusted with triethylamine to 3.0 and acetonitrile (85:15, v / v). The validation method yielded good results demonstrated statistically that the method was linear, precise, accurate, specific and robust. No interference from any components of the pharmaceutical dosage forms was observed.