zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1172Research ArticleСтатьиПроизводные спектрофотометрические методы определения сукцината солифенацина в нерасфасованном виде и в составе таблетокDerivative Spectrophotometric Methods for Determination of Solifenacin Succinate in Bulk and in Tablet FormulationSinghP.SinghP.

Чандигарх

Chandigarh

BaliA.BaliA.

Чандигарх

Chandigarh

alka.bali@rediffmail.comИнститут фармацевтических наук Центра перспективных исследований UGC, Панджабский университетUniversity Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University202228112022896830835Copyright © Singh P., Bali A., 20222022Singh P., Bali A.Singh P., Bali A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://zhps.ejournal.by/jour/article/view/1172

Для количественного определения сукцината солифенацина в нерасфасованном виде и в таблетках разработан спектрофотометрический метод производных нулевого и первого порядка. Предварительное спектрофотометрическое определение лекарственного средства проводили в 0.1 N HCl, метаноле и фосфатном буфере рН 2.0 с 33 параметрическими вариациями. Выбранный метод с тремя параметрическими вариациями на основе методов “пик-ноль” (P-0) и “пик-пик” (P-P) оценен на стабильность, что указывает на потенциал для оптимальных решений. Метод подтвержден в соответствии с принципами ICH в отношении линейности, точности, прецизионности, предела обнаружения (LOD), предела количественной оценки (LOQ) и надежности. Отличная линейность отмечена в диапазоне концентраций 1.0–80.0 мкг/мл для всех трех вариантов метода. LOD для предлагаемого метода 0.03–0.16 мкг/мл, LOQ 0.09–0.48 мкг/мл. 

Rapid, sensitive, reproducible and cost-effective zero-order and first-order derivative spectrophotometric method has been developed for the quantification of solifenacin succinate in bulk and its tablet formulation. Preliminary spectrophotometric determination of the drug was carried out in 0.1 N HCl, methanol and in phosphate buffer pH 2.0 with a total of thirty-three parametric variations. The selected method with three parametric variations employing peak-zero (P-0) and peak-peak (P-P) techniques was assessed for stability, indicating a potential for force-degraded solutions. The method was validated in accordance with the ICH guidelines with respect to linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. Excellent linearity was noted in a concentration range of 1.0–80.0 μg/mL for all three method variants. Limits of detection for the proposed method ranged from 0.03–0.16 μg/mL and limits of quantitation were found to be in the range of 0.09–0.48 μg/mL, respectively. Excellent recovery of the drug was obtained from its marketed tablet formulation with the proposed method. 

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The authors declare that there are no conflicts of interest present.