zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-2039Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESЭкологичные УФ-спектрофотометрические методы оценки гидрохлорида алфузозина и тадалафила в нерасфасованном виде и комбинированных лекарственных формахEco-Friendly Tandem Validated UV Spectrophotometric Methods for Estimation of Alfuzosin Hydrochloride and Tadalafil in Bulk and Combined Dosage FormsSanthoshD. V.SanthoshD. V.

Кодунтирапулли, Палаккад, Керала

Kodunthirapully, Palakkad, Kerala

KuttyS. V.KuttyS. V.

Кодунтирапулли, Палаккад, Керала

Kodunthirapully, Palakkad, Kerala

SurendranS. A.SurendranS. A.

Кодунтирапулли, Палаккад, Керала

Kodunthirapully, Palakkad, Kerala

HaribabuY.HaribabuY.

Кодунтирапулли, Палаккад, Керала

Kodunthirapully, Palakkad, Kerala

HassanarA.HassanarA.

Кодунтирапулли, Палаккад, Керала

Kodunthirapully, Palakkad, Kerala

AshokanA.AshokanA.

Кодунтирапулли, Палаккад, Керала

Kodunthirapully, Palakkad, Kerala

AravindA.AravindA.

Кодунтирапулли, Палаккад, Керала

Kodunthirapully, Palakkad, Kerala

AbsherM.AbsherM.

Кодунтирапулли, Палаккад, Керала

Kodunthirapully, Palakkad, Kerala

Фармацевтический колледж Грейс, Керальский университет медицинских наукDepartment of Pharmaceutical Analysis, Grace College of Pharmacy, Kerala University of Health Sciences202526112025926827827Copyright © Santhosh D.V., Kutty S.V., Surendran S.A., Haribabu Y., Hassanar A., Ashokan A., Aravind A., Absher M., 20252025Santhosh D.V., Kutty S.V., Surendran S.A., Haribabu Y., Hassanar A., Ashokan A., Aravind A., Absher M.Santhosh D.V., Kutty S.V., Surendran S.A., Haribabu Y., Hassanar A., Ashokan A., Aravind A., Absher M.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/2039

Разработан экологичный УФ-спектрофотометрический метод определения тадалафила и гидрохлорида алфузозина в комбинированной лекарственной форме путем объединения двух методов,  обеспечивающих минимальное воздействие на окружающую среду: метода поправки на поглощение (метод А) и метода одновременных уравнений (метод В). Тадалафил продемонстрировал нулевое поглощение при 340 нм в методе А, тогда как гидрохлорид алфузозина показал поглощение при 290 и 340 нм. В методе B используются максимумы поглощения 244 нм для гидрохлорида алфузозина и 283 нм для тадалафила. В методе A обнаружена линейная зависимость с коэффициентами корреляции 0.999 для гидрохлорида алфузозина и 0.999 для тадалафила. В методе B коэффициент корреляции составил 0.999 и 0.996 соответственно. Все параметры валидации разработанных методов соответствуют требованиям ICH. Разработанный УФ-спектрофотометрический метод получил оценку AGREEprep 0.81, оценку MoGAPI 77 и оценку BAGI 72.5. 

Tadalafil and alfuzosin hydrochloride are frequently used together to treat benign prostatic hyperplasia. Recent approved combination of these medications was selected because only one study has investigated their synthetic mixture, and no research has examined the pharmaceutical dosage form using UV analysis. The purpose of this study is to create and verify a green UV spectrophotometric technique for the simultaneous measurement of tadalafil and alfuzosin hydrochloride in their combination dose form by developing two methods to ensure the lowest environmental impact, i.e., absorption correction method (method A) and the simultaneous equation method (method B). Tadalafil exhibited zero absorbance at 340 nm in method A, whereas alfuzosin hydrochloride exhibited absorption at 290 and 340 nm. Absorption maxima of 244 nm for alfuzosin hydrochloride and 283 nm for tadalafil are used in method B. A linear relationship in method A was found with correlation coefficient value of 0.999 for alfuzosin hydrochloride and 0.999 for tadalafil. While in method B, correlation coefficient of 0.999 and 0.996, respectively. All the validation parameters for the developed methods were found to be within the ICH guidelines’ limits. The developed UV spectrophotometric method received an AGREEprep score of 0.81, MoGAPI score of 77 and BAGI score of 72.5. For routine quality monitoring of alfuzosin hydrochloride and tadalafil, this approach offers a straightforward, affordable, and environmentally friendly substitute that preserves analytical performance while promoting sustainable pharmaceutical analysis. If successfully implemented, it can help labs lessen their environmental impact without compromising the accuracy of their analyses.

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