Simulated Gastric Chloride Acid

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Dissolution test will be carried out in a simulated gastric fluid (SGF) using hydrochloride acid or a neutral buffer phosphate solution. The simulated gastric fluid without enzyme (SGF) at pH 1.2 and pH 3 containing sodium chloride and hydrochloric acid in 900ml deionized water will be prepared. Thus, the pH will be adjusted using hydrochloride(Ghazal et al., 2015). The simulated gastric media containing milk (whole milk, skimmed milk) will be prepared using an equal volume of milk and (SGF) pH 1.2(Ghazal et al., 2015). Amino acids lysine, glycine and saturated solution aspartic acid each at 1% w/v will be chosen to represent the basic, neutral and acidic amino acids at both gastric acidic condition pH 3 and the simulated intestinal fluid pH 6.8 (Ghazal et al., …show more content…
The mixture will be centrifuged at a suitable speed for a particular period. The mixture will then be filtered. The filtrates will then be diluted with mobile phase then be analysed by HPLC (high-performance liquid chromatography) to determine quantitatively the concentration of the drug.
The intrinsic dissolution rate will be determined using a stationary disk apparatus. The dissolution test will be performed using a USP apparatus 2 (paddle).The temperature will be set at 37◦C and rotation speed at 100rpm will be applied (United States Pharmacopeia 2015). The drug will then be extracted from the mixed media using the liquid-liquid extraction (Ghazal et al., 2015), the upper organic layer will be evaporated to dryness with the use of nitrogen at 60°C and the residue sonicated for few minutes, and then will be analysed using HLPC.
The following analysis will be performed to determine if there was any change in the polymorphic form of the drug or to characterise and provide structure information of the physical state of the dipyridamole. X-ray diffractometry, differential scanning calorimetry and infrared

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