It was 100% soluble in range of solvents like alcohol and chloroform. The solubility was less in distilled water but solubility tremendously increased in aqueous solutions like normal saline, dextrose solution, glycerol, propylene glycol. Ninety eight percent drug was soluble in 0.1 N HCl, and alcohol
containing HCl solution. Drug had fairer solubility in phosphate buffer saline of basic range. As the pH of buffer saline increased the solubility decreased (Table 2). selleck kinase inhibitor Solid state stability of AS was conducted, maximum stability was found at 2–8 °C, 60% RH in 24 h. On increasing the temperature and % relative humidity drug degradation was noted (Table 3). The drug was stored at temperature 2–8 °C, 25 °C, 40 °C and 50 °C with humidity 60% RH, 65% RH, 70% RH, Galunisertib purchase 75% RH and 60% RH respectively. As temperature was increased humidity was also increased up to 40 °C. With storage temperature 50 °C humidity was kept 60% RH so as to distinguish the
degradative effect of temperature in comparison to humidity. Drug had maximum stability at storage temperature 2–8 °C with 60% RH up to 3 weeks. Storage at 25 °C and 65% RH showed fairer stability up to 24 h only. Storage time of 1st week, 3rd weeks, 5th weeks at 25 °C temperature and 65% RH showed 92 ± 0.54%, 90 ± 0.24% and 90 ± 0.38%, drug was remaining. Hence the degradation rate seems to be slow. However storage of AS at temperature 40 °C along with humidity 75% RH, the drug was not stable as it degraded and amount of drug remaining was found to be: 90 ± 0.68%, 86 ± 0.04%, 80 ± 0.88%, 78 ± 0.06% at 24 h, one week, three week and five week of storage timing respectively. These data suggests drug’s instability at 40 °C temperature (Table 3). The degradation pattern at storage 50 °C temperature and humidity 60% RH reveals that less amount of drug was degraded as compared
to storage temperature 40 °C and 75% RH. Hence degradation of drug was more moisture related i.e. increment in temperature have very little effect on the same. It may thus be concluded that AS in solid state Sodium butyrate is quite stable in refrigerated storage. Hydrolytic degradation studies for AS were performed at different pH in pharmaceutical buffers. As the pH decreased i.e. acidity increased, the degradation of AS increased. The drug was most stable at pH 8 at both temperatures of storage temperature i.e. 2–8 °C and 25 °C (Table 4). Ageing increased degradation of HCQ drug as 88.07 ± 0.5% drug was remaining at storage temperature 2–8 °C for 3 weeks as compared to 94 ± 0.2% drug remaining when stored for one week. HCQ Sulphate was found to be stable at room temperature. Increment in temperature up to 25 °C only 1% drug was degrades after storage of 24 h (Table 5). The photo reactivity screening of HCQ gave idea of packaging the formulation in light resistant container as after 5th week of storage at 25 °C only 80 ± 0.38% HCQ was remaining.