The effect of Temperature and direct Sun light for Stability of Metrondezole Suspension

Abstract

This research was performed to evaluate the stability of Metronidazole active pharmaceutical ingredient at oral suspension products at three different conditions: 1. Direct sunlight. 2. At room temperature. 3. At 50 °C. To determine the percent of Metronidazole API at different products; an HPLC method was used to detect the percent of Metronidazole. The HPLC column that used is an stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5µm), mobile phase is a mixture of volumes of 1.25 % w/v solution of ammonium acetate , adjusted to pH 7.0 with dilute acetic acid or dilute ammonia R 1 , as appropriate , and 60 volumes of methanol and (c) with flow rate 1.0 ml/min and detection wavelength 310 nm. Assay of Sample (1) was found to be 103.59792 %, Assay of Sample (2) was found to be 105.77888 % and Assay of Sample (3) was found to be 105.93496 % which indicates to; all three samples were stable when exposed to direct sunlight for 5 days and exposed to 50 °C when exposed to 50 °C for 5 days.