Abstract
The objective of the study was an attempt to examine the usefulness of the most frequently used multivariate techniques in the pharmaceutical analysis such as cluster analysis (CA) and principal component analysis (PCA), as the supporting methods for identification of the physicochemical incompatibility occurring between drugs and excipients. The binary physical mixtures of acetazolamide, atenolol, baclofen, hydrocortisone and piroxicam with the excipients such as lactose, mannitol, methylcellulose, starch, magnesium stearate and talc, mixed in the molar or mass ratios of 9:1, 7:3, 1:1, 3:7 and 1:9, were studied. The possibility of incompatibilities between both components of the mixtures under study was investigated based on the results obtained with the help of differential scanning calorimetry (DSC), differential thermal analysis (DTA), thermogravimetry (TG) as well as infrared spectroscopy (IR) and hot-stage microscopy (HSM). The obtained results were interpreted with the help of chemometric techniques. Based on these results it can be shown that the physicochemical incompatibilities in the binary physical mixtures of acetazolamide with lactose, mannitol, methylcellulose, starch and baclofen with lactose, magnesium stearate are probable. It was confirmed by the results of the statistical analysis which showed that CA and PCA techniques are very helpful in the interpretation of thermoanalytical data.
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