Objective: Develop and validate a novel, sensitive, precise and straightforward UV spectrophotometric method to determine the amount of dioscin in tribulmon tablets. Methods: tribulmon tablets were prepared in the laboratory from medicinal plants Tribulus Terrestris L, native to Mongolia. Extract solutions were prepared from a single batch of tribulmon tablets, and the amount of dioscin was determined by UV spectrophotometric method using a calibration curve of known solutions of the dioscin. A chromogenic reaction was used to determine the amount of dioscin in the tablets. The maximum absorption was 201 nm. Validation parameters were evaluated following ICH guidelines. Results: The correlation coefficient of linearity for the UV spectrophotometric method was 0.9996. The standard working solution was linear from 3.2 to 18.9 μg/mL. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) were 1.9 μg/ mL and 5.9 μg/mL, respectively. The recovery test accuracy was ranged from 97.9 to 100%. The %RSD for repeatability and intra-day precision was 0.45%, 0.13-0.50%, respectively. The %RSD for robustness was 0.26% to 0.40%, respectively. Conclusion: Based on the results of the proposed UV spectrophotometric method, the method we developed to determine dioscin content in tribulmon tablets from Tribulus Terrestris L is sensitive, precise, stable and straightforward. The test's validation parameters comply with ICH requirements.
It has been noted in the Mongolian traditional medicine sources that aerial parts, fruits and seeds of the Tribulus terestris L. plant are beneficial for renal diseases and improvement of renal function. In the current marketplace, herbal medicinal products for sexual potency and their production have been developing rapidly. Therefore, with the goal of appropriate usage of national resources and to provide a substitute for the imported products, a technological study on the extraction of liquid extracts from the upper part of the Tribulus terrestris L. plant was carried out. In the first part of this herbal tablet development technology research the appropriate solvent concentrations for the extraction from the plant raw materials, which are the main technological indicators, were determined by the total saponin concentrations in the plant by spectrophotometric method. As a result of the study the ideal extracellular solvent for extraction was determined, a 70% ethanol and the total saponin content was 15.53 mg/ml or 0.77%. Зэлэн зангуу ургамлын (Tribulus terristris L.) шингэн ханды технологийн зарим үзүүлэлтийг тогтоосон судалгааны үр дүнгээс Хураангуй: Монголын УАУ-ны эх сурвалжуудад Зэлэн зангуу ургамлын (Tribulus terristris L.) газрын дээд хэсэг, үр жимсийг нь бөөрний өвчинд тустай, бөөрний тамир сайжруулдаг хэмээн эмийн үйлдлийг нь тэмдэглэн үлдээсэн байдаг. Орчин үед бэлгийн үйл ажиллагааг сайжруулах ургамлын гаралтай эмийн зах зээлд Зэлэн зангуу ургамлын найрлага бүхий биологийн нэмэлт бүтээгдэхүүн, эмийн үйлдвэрлэл эрчимтэй хөгжиж байна. Иймд бид эх орны ургамлын нөөцийг зохистой ашиглан, импортын эмийн бүтээгдэхүүнийг орлох эм гарган авах зорилгоор Зэлэн зангуу ургамлын газрын дээд хэсгээс шахмал эмийн хэлбэр гарган авах судалгааг хийж гүйцэтгэсэн. Энэхүү шахмал эмийн технологийн судалгааны ажлын эхний хэсэг болох шингэн ханд гарган авах, экстрагентийн тохиромжтой концентрацийг тогтоох судалгааг уг ургамлын биологийн идэвхт бодис болох нийлбэр сапонины агууламжаар, спектрофотометрийн аргаар судлан тогтоолоо. Судалгааны ажлын үр дүнд шингэн ханд гарган авах экстрагентийн тохиромжтой концентраци нь 70%-н этанол байсан бөгөөд уг ханданд агуулагдах нийлбэр сапонины агууламж нь дунджаар 15.53 мг/мл буюу 0.77% байгааг тогтоолоо. Түлхүүр үгс: Зэлэн зангуу, экстрагентийн концентраци, нийлбэр сапонин, спектрофотометр
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