The amount of the MMF present in analysed formulations was presented in Table 6. The stability of drug towards the degradation conditions was explained BIBW2992 mw in terms of percent of drug obtained after time of degradation. In the present investigation

the stability of the drug was studied under 0.1 HCl, 0.1 N NaOH, 1% H2O2, photolytic and thermal conditions at three spike levels. At each condition three replicate measurements were taken, the percent of drug found after the period of degradation was calculated and mean percent of drug was determined. In acid, base and peroxide degradation studies, MMF stock solutions at LQC, MQC and HQC concentrations were taken into three microcentrifuge tubes; 100 μL of 0.1 N HCl, 0.1 N NaOH or 100 μL of 1% H2O2 solution was added in each tube and then kept a side for 24 h. The same amount of MMF stock solutions at LQC, MQC and HQC concentrations were taken into three microcentrifuge tubes methanol was added to the samples to keep the equality amount of the sample content for the analysis. Further the analysis was done as per the optimized procedure and the percent of degradation was calculated comparing the response (peak area) of the

degraded compound and freshly prepared solutions. The percent of drug found in between 91.18 and 96.70, 93.27 and 98.72 and 90.15 and 96.01 in 0.1 HCl, 0.1 N NaOH and 1% H2O2 respectively. In case of photo stability MMF samples (LQC and HQC) should be exposed to light providing an overall illumination of not less than 1.2 million lux h and an integrated near

ultraviolet MK-8776 mouse energy of not less than 200 W h/m2 to allow direct comparisons to be made between the substance and product. Samples may be exposed side-by-side with a validated Tolmetin chemical actinometric system to ensure the specified light exposure is obtained, or for the appropriate duration of time when conditions have been monitored using calibrated radiometers/lux meters. The percent of drug found in between 91.45 and 96.45 in photolytic conditions. In thermal stability, samples were placed in two test tubes, two thermocouples are inserted into the tubes and one in the oven. Thermocouples and the covered tubes are placed in the oven. The temperature difference between test samples is measured for 4 h after the sample reach 55 °C. Evidence of decomposition of the sample is determined by the samples compare with 0 h–4 h. The percent of drug found in between 93.90 and 98.19 in thermal conditions. The results were presented in Table 7(a)–(e). The developed LS/MS/MS method was found to be very simple, highly precise and accurate; therefore this may be suggested as an alternative method for routine quality control. All authors have none to declare. One of the authors TVBR wishes to convey his gratitude to T.G.