Abstract

EFFECT OF ACCELERATED AGING CONDITIONS ON IN-VITRO DISSOLUTION STUDIES OF MOXIFLOXACIN HYDROCHLORIDE AND CEFIXIME TRIHYDRATE FROM ITS COMBINED TABLET DOSAGE FORM BY HPLC ASSAY METHODS.

Mirza Shahed Baig* and M. H. G. Dehghan

ABSTRACT

In-vitro dissolution studies for moxifloxacin hydrochloride and cefixime trihydrate from its combined tablet dosage form was developed and validated successfully as per ICH guidelines. Dissolution studies were performed using USP Type II apparatus for period of 45 min, in 0.1N HCl at 50 RPM. Both the drugs shows complete dissolution profile within 30 min. Exposure of tablets to ICH accelerated stability condition 400C ± 20C/75% RH ± 5% for 6 months and photolytic studies in an open dish to light for 30 days, using a combination of cool white and ultraviolet fluorescent lamps in a photostability chamber. Exposure energy was minimum of 1.2 million lux h fluorescent light and 200W h/m2 UV. Dissolution samples were analyzed by newly developed HPLC method comprising of mobile phase as 0.01M potassium dihydrogen orthophosphate buffer: methanol (40:60 v/v) with 1% Triethylamine (2 ml / 100 ml mobile phase) and its pH adjusted to 3.5 with Glacial acetic acid and detection was executed on PDA detector at 293 nm. The retention time (RT) of moxifloxacin hydrochloride and cefixime trihydrate was found to be 4.24 ± 0.2 and 2.32 ± 0.2 min respectively. Results of analysis demonstrated that accelerated aging results in rapid increases in tablet hardness, and changes in water content upon storage leads to decrease in dissolution rate. The tablet matrix appears to rapidly absorb atmospheric moisture, as demonstrated by tablet weight gain, this shows changes in dissolution curves as compared to fresh marketed formulation indicating influence on drug product stability.

Keywords: Reverse phase HPLC, dissolution studies, accelerated aging conditions, moxifloxacin hydrochloride, cefixime trihydrate.