Medications with an antiseptic effect for the treatment of pain in the mouth and throat are especially relevant in the autumn-winter period. The composition of these drugs, in addition to the active substances with antiseptic action, also include auxiliary substances, for example, synthetic food colorants (SFC). The need to control the amount of SFC consumed is an important task, since exceeding the permissible daily intake can lead to allergic reactions, hyperactivity in children. Two chemometric methods applied were partial least squares (PLS) and principal component regression (PCR). These approaches were used to quantify the colorants in model colorants solutions and "Strepsils" lozenges aqueous solution based on information included in the visual absorption spectra. The calibration PLS and PCR models were evaluated by internal validation (prediction of compounds in its own designed training set of calibration) and by external validation over pharmaceutical preparation. The accuracy of the methods was evaluated through the root mean square error of prediction (RMSEP). The results of PLS and PCR methods were compared and the best models for the system were obtained with PCR. Ultimately, a method was developed for the chemometric-assisted spectrophotometric determination of E110 in the presence of E124 in the "Strepsils" tablets, which is characterized by simplicity and rapidity.
The dosing uniformity indicator of the «Papazol» tablets of two manufacturers was evaluated according to the Russian State Pharmacopoeia XIV and by Principal Component Analyis (РСА). The pharmacopoeial method showed that “Papazol” tablets (“Pharmstandart-Leksredstva”) satisfy the requirements for dosage uniformity. “Papazol” tablets (“Irbit Chemical Pharmaceutical Plant”) do not meet the requirements for dosing uniformity. The possibility of the PCA method application for rapid testing of “Papazol” tablets for dosage uniformity was investigated. The results obtained are consistent with the data obtained using the pharmacopoeial direct determination method. The objective of this study was to present the spectrophotometry method coupled with chemometrics approaches as a simple, cost-effective, and accurate for the dosing uniformity indicator testing in pharmaceutical formulation.
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