B.N. Suhagia

Enrofloxacin (EFX) is a third generation Fluoroquinolone with a broad spectrum antibacterial activity. Enrofloxacin hydrochloride is 1-cyclopropyl-7-(4-ethylpiperazin-1-yl)-6-fluoro-4-oxo-1, 4-dihydroquinoline-3-carboxylic acid. A Sensitive, simple and rapid reverse phase high performance liquid chromatographic method was developed for the determination of Enrofloxacin (EFX) in tablet dosage form. The chromatographic separation was performed on a Kromasil C-18 column (250mm x 4.6 mm x 5µ) in isocratic mode using phosphate buffer pH 3:Methanol (40:60 v/v), pH adjusted to 3.0 using orthophosphoric acid as mobile phase at a flow rate of 1.0 ml/min with column temperature 30 OC. The quantification was performed at 280 nm. The method showed good linearity over the concentration range of 5-25 µg/ml with correlation coefficient r2 0.9996. LOD and LOQ was found to be 1.0 and 3.0. The developed RP HPLC method was applied to EFX in tablet dosage form and results were found to be in agreement with the label claim.

A simple, specific, selective and accurate stability-indicating reversed phase high performance liquid chromatographic method was developed for simultaneous determination of Diclofenac potassium (DIC), Paracetamol (PCM) and Methocarbamol (MET). An isocratic RP-HPLC was achieved on younglin HPLC system using Varian C18 (250 Χ 4.6 mm i.d, 5 μm particle size) column with the mobile phase containing mixture of Methanol:water (80:20,v/v). The flow rate was 0.8 ml/min and the eluent was monitored at 225nm. The retention times of DIC, PCM and MET were found to be 3.51, 6.42 and 9.90 min respectively. The linearity was established for DIC, PCM and MET in the range of 10-60 µg/ml, 65-390µg/ml, 100-600µg/ml respectively. The percentage recoveries of DIC, PCM and MET were found to be in the range of 99.73%±0.109, 99.59%±0.085 and 99.50%±0.16 respectively. The LOD for DIC, PCM and MET were found to be 0.15, 2.40 and 1.82μg/ml respectively, while LOQ were 0.48, 7.29 and 5.53μg/ml respectively. All three drugs were subjected to acid, alkali, oxidation, and dry heat degradation. The degradation studies indicated DIC, PCM and MET showed degradation in acid, alkaline, H2O2, and in dry heat condition. The degradation products of DIC, PCM and MET were resolved well from the pure drug with significant differences in their retention time values. This method was also successfully employed for simultaneous quantitative analysis of DIC, PCM and MET in bulk drugs and formulations. The developed method is stability indicating and separate degradants and can be used to determine the stability of samples.