Development and Validation of Methods of Quantitative Determination of Loratadine in Tablets
Methods for the quantitative determination of loratadine tablets by differential spectrophotometry and photo-colorimetry have been developed. During the procedure parameters (range of application methods, stability, specificity, robasnist, convergence, internal laboratory accuracy (precision), accuracy, reproducibility) have been considered. The results indicate that the method photo-colorimetry has not met modern criteria for analytical methods for quantitative determination of parameters such as stability, accuracy and linearity, so other validation parameters (robasnist, convergence and inter-laboratory precision) have been determined only by spectrophotometric methods. It is found that the technique of quantitative determination of loratadine by differential spectrophotometry is accurate, correct, reproducible and linear, to determine its suitability for use in pharmaceutical analysis.
Korobko DB, Polyauk OB, Logoyda LS, et al. Development and validation of methods for identification of loratadine tablets. Actual questions of pharmaceutical and medical science and practice. 2014; 1:55–8.
Ukrainian Scientific Center pharmacopoeia quality medicine. 2nd ed. Kharkiv: State Enterprise; 2014. p. 724.
Scientific and Expert Centre pharmacopoeia. 1st ed. Kharkiv: State Enterprise; 2008. p. 620.
Grizodub AI. Reproducibility of pharmacopoeial methods of spectrophotometric quantitation of medicines in different laboratories. Farmakom. 2004; 2:20–34.
Grizodub AI. Standard procedures validation techniques drug of quality control. Farmakom. 2006; 1-2:35–44.
Guidelines for the validation of methods of analysis of medicines. Moscow: 2007. p. 57.
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