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.
