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A novel validated and stability indicating RP-HPLC method for the determination of doripenem in bulk and pharmaceutical formulations

Veldi Venugopal, Golkonda Ramu, Chintala Rambabu

A simple, rapid, precise and accurate stability indicating reverse phase liquid chromatographicmethod (RP-HPLC) was developed for the determination of a beta-lactum antibiotic agent doripenem Doripenem (DPN) in pure and dosage forms. The degradation products formed under different stress conditions were successfully separated on a chromosil C18 column using a mobile phase of mixture of water, methanol and ortho phosphoric acid in the ratio 78:20:02 (v/v/v) at a rate of flow of 1.0 mL/min and were detected at a suitable wavelength of 290nm. The degradation products thus formed were well resolved with an acceptable retention time. The developed method was statistically validated for precision, accuracy, linearity, ruggedness, robustness, forced degradation, solution stability sensitivity and selectivity. Recovery studies of the dosage form were also carried out at three different concentration levels with in the linearity limits and the calculated percent of relative standard deviation (% RSD) was found to be acceptable. The response of the instrument (peak area) with concentration was observed to be linear in the range of concentration 5.0- 40 µg mL-1. Due to its simplicity, rapidity and accuracy the proposedmethod may be considered as an alternative method for routine quality control analysis in any pharmaceutical laboratory.