zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1434Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESУФ-спектрофотометрические методы производных для определения трандолаприла в нерасфасованном виде и в таблетированном составеStability Indicating Derivative Spectrophotometric Methods for Determination of Trandolapril in Bulk and in FormulationJaiswalL. K.JaiswalV. K.

Чандигарх

Vinod Kumar Jaiswal

Chandigarh

BaliА.BaliA.

Чандигарх

Alka Bali

Chandigarh

alka.bali@rediffmail.comИнститут фармацевтических наук Центра перспективных исследований UGC, Пенджабский университетUniversity Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University202325112023906971971Copyright © Jaiswal L.K., Bali А., 20232023Jaiswal L.K., Bali А.Jaiswal V.K., 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/1434

Трандолаприл — пероральный ингибитор ангиотензинпревращающего фермента (АПФ), одобренный USFDA для лечения гипертонии и застойной сердечной недостаточности. Описана валидация УФ-спектрофотометрических методов производных нулевого и первого порядка для оценки трандолаприла в нерасфасованном виде и таблетированной форме. Предварительное спектрофотометрическое определение препарата проведено в фосфатном буфере рН 2.0 или 0.1 н HCl. Исследовано 17 вариантов параметрического метода, из которых три варианта с использованием методов пик-ноль (P-0) и пик-пик (P-P) проверены с точки зрения линейности, точности, прецизионности и устойчивости. Разработанные методы также оценены на стабильность, указывающую на возможность деградации растворов. Линейность наблюдалась в диапазоне концентраций 1.0–70.0 мкг/мл с хорошим коэффициентом корреляции r2 = 0.9981–0.9998. Для предложенных методов LOD = 0.88– 1.23 мкг/мл, LOQ = 2.66–6.09 мкг/мл. Предложенные методы использованы для количественного определения препарата в его таблетированной форме с выходом 90–98%.

Trandolapril is an oral angiotensin-converting enzyme (ACE) inhibitor approved by the USFDA for the therapy of hypertension and congestive heart failure. This paper describes the validation of zero- and firstorder derivative UV spectrophotometric methods for the estimation of trandolapril in bulk and in its marketed tablet formulation. Preliminary spectrophotometric determination of the drug was carried out in phosphate buffer pH 2.0 or 0.1 N HCl. A total of 17 parametric method variants were investigated out of which three variants employing peak–zero (P–0) and peak–peak (P–P) techniques were validated with respect to linearity, accuracy, precision, and robustness. The developed methods were also assessed for stability indicating potential in force degraded solutions. Linearity was observed in the concentration range of 1.0–70.0 μg/mL with an excellent correlation coefficient (r2) ranging from 0.9981–0.9998. The limits of assay detection values were found for the range of 0.88–1.23 μg/mL, and quantitation limits ranged from 2.66–6.09 μg/mL for the proposed methods. The proposed methods were extended to the quantification of the drug in its marketed tablet formulation with good recoveries (90–98%).

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