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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.
Tatiana Rusanova,Nataliya Shestopalova,Yuliya Fomina,Nataliya Burmistrova, andDmitriy Silaev
"Quality control of tablets "Papazol" by spectrophotometry using chemometrics", Proc. SPIE 11845, Saratov Fall Meeting 2020: Optical and Nanotechnologies for Biology and Medicine, 118450Q (4 May 2021); https://doi.org/10.1117/12.2590713
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Tatiana Rusanova, Nataliya Shestopalova, Yuliya Fomina, Nataliya Burmistrova, Dmitriy Silaev, "Quality control of tablets "Papazol" by spectrophotometry using chemometrics," Proc. SPIE 11845, Saratov Fall Meeting 2020: Optical and Nanotechnologies for Biology and Medicine, 118450Q (4 May 2021); https://doi.org/10.1117/12.2590713