STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DORIPENEM IN BULK AND IN SOLID DOSAGE FORM BY RP-HPLC

Abstract

A robust and reliable high performance liquid chromatographic (HPLC) approach was developed and validated for the analysis of Doripenem in pharmaceutical dosage form. The method is characterised by its simplicity, selectivity, precision, and capacity to accurately determine the stability of Doripenem. The experimental setup included the use of a Hypersil BDS-C18 column (250 X 4.6 mm ID, 5 µm) as the stationary phase in a chromatographic system. The mobile phase consisted of a combination of methanol and potassium dihydrogen orthophosphate with a pH of 6.7, in a ratio of 20:80. The flow rate of the mobile phase was set at 1 ml/min. The detection of the eluents occurred at a wavelength of 290 nm. The observed retention time for Doripenem was 5.56 minutes. Doripenem underwent acid and alkali hydrolysis, oxidation, photochemical degradation, and heat degradation. The results obtained from the linear regression analysis of the calibration plot demonstrated a strong linear connection within the concentration range of 70 – 130 µg/ml, as shown by a correlation coefficient value of 0.9995. The methodology was assessed to determine its precision, accuracy, ruggedness, and robustness. The medication experiences deterioration when exposed to environments characterised by acidity, alkalinity, photochemical reactions, and thermal stress. The active medicinal component exhibited distinct retention periods for each of its degradation product peaks, indicating successful resolution. The approach's ability to successfully isolate the medication from its degradation products renders it suitable for use as a stability-indicating method.