Development of a new certified reference material of diosgenin using mass balance approach and Coulometric titration method

Gong, Ningbo; Zhang, Baoxi; Fan, Hongyuan; Du, Haizhou; Du, Guanhua; Gao, Zhaolin; Lü, Yang

doi:10.1016/j.steroids.2014.08.019

Cited by 6 publications

(15 citation statements)

References 25 publications

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“…Therefore, it was stated that, by mass balance method and CT method, the purity of the analyte was determined, presenting an average of 99.80% with an extended uncertainty of 0.37% ( k = 2). These methods, in addition to ensure validation of measurement methods, can also be used to improve the accuracy of measured data as well as control the quality of diosgenin in traditional herbs and pharmaceutical formulations [130]. …”

Section: Methodsmentioning

confidence: 99%

Diosgenin: Recent Highlights on Pharmacology and Analytical Methodology

Jesus

Martins

Gallardo

et al. 2016

Journal of Analytical Methods in Chemistry

209

125

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Diosgenin, a steroidal sapogenin, occurs abundantly in plants such as Dioscorea alata, Smilax China, and Trigonella foenum graecum. This bioactive phytochemical not only is used as an important starting material for the preparation of several steroidal drugs in the pharmaceutical industry, but has revealed also high potential and interest in the treatment of various types of disorders such as cancer, hypercholesterolemia, inflammation, and several types of infections. Due to its pharmacological and industrial importance, several extraction and analytical procedures have been developed and applied over the years to isolate, detect, and quantify diosgenin, not only in its natural sources and pharmaceutical compositions, but also in animal matrices for pharmacodynamic, pharmacokinetic, and toxicological studies. Within these, HPLC technique coupled to different detectors is the most commonly analytical procedure described for this compound. However, other alternative methods were also published. Thus, the present review aims to provide collective information on the most recent pharmacological data on diosgenin and on the most relevant analytical techniques used to isolate, detect, and quantify this compound as well.

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Section: Methodsmentioning

confidence: 99%

Diosgenin: Recent Highlights on Pharmacology and Analytical Methodology

Jesus

Martins

Gallardo

et al. 2016

Journal of Analytical Methods in Chemistry

209

125

View full text Add to dashboard Cite

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“…Èíîãäà â êà÷åñòâå P î èñïîëüçóþò õðî-ìàòîãðàôè÷åñêóþ ÷èñòîòó ïèêîâ, òî åñòü ìåòîä íîðìàëèçàöèè áåç ïîïðàâî÷íûõ êîýôôèöèåíòîâ; îäíàêî òàêîé ñïîñîá íåñåò âûñîêèé ðèñê íåêîððåêòíîé àòòåñòàöèè ÑÎ è, ïîýòîìó, òðåáóåò ïðèâëå÷åíèÿ äîïîëíèòåëüíûõ ìåòîäîâ òèïà äèôôåðåíöèàëüíîé ñêàíèðóþùåé êàëîðèìåòðèè (ÄÑÊ) è ßÌÐ; ïðè ýòîì àòòåñòîâàííîå çíà÷åíèå ÑÎ ïðåäñòàâëÿþò â âèäå óñðåäíåííîãî çíà÷åíèÿ ñîäåðaeàíèÿ îñíîâíîãî âåùåñòâà â ÑÎ, ïîëó÷åííîãî õðîìàòîãðàôè-÷åñêèì è äðóãèìè ìåòîäàìè, íàïðèìåð, ñì. [24]. Íà ïðàêòèêå â áîëüøèíñòâå ñëó÷àåâ íåò íåîáõîäèìîñòè ïðè àòòåñòàöèè ÑÎ ó÷èòûâàòü âñå ñëàãàåìûå â ôîðìóëàõ (1) è (2).…”

Section: âû÷èñëåíèå àòòåñòîâàííîãî çíà÷åíèÿ ñî ìåòîäîì "áàëàíñà ìàññ"unclassified

“…ãäå k -êîýôôèöèåíò îõâàòà; U (Hom ) è U (Stab ) -ñòàíäàðòíûå íåîïðåäåëåííîñòè, ïîëó÷åííûå ïðè îöåíêå îäíîðîäíîñòè ñîäåðaeàíèÿ (ãîìîãåííîñòè) îñíîâíîãî âåùåñòâà â ïðîáàõ àòòåñòóåìîé ñóáñòàíöèè è ïðè îöåíêå åå ñòàáèëüíîñòè, à U (X Att ) -êîìáèíèðîâàííàÿ íåîïðåäåëåííîñòü ñîäåðaeàíèÿ îñíîâíîãî âåùåñòâà â àòòåñòóåìîé ñóáñòàíöèè, âûðàaeåííàÿ ÷åðåç êîðåíü êâàäðàòíûé èç ñóììû êâàäðàòîâ ñòàíäàðòíûõ íåîïðåäåëåííîñòåé ñëàãàåìûõ â ôîðìóëå (1), è íåîïðåäåëåííîñòè, ñâÿçàííîé ñ ïðåäåëîì îáíàðóaeåíèÿ ïðèìåñåé U (LOD ) [24]:…”

Section: âû÷èñëåíèå íåîïðåäåëåííîñòè àòòåñòîâàííîãî çíà÷åíèÿ ñîunclassified

“…Â ñîîòâåòñòâèè ñ (16) äëÿ ðàñ÷åòà êîìáèíèðîâàííîé íåîïðåäåëåííîñòè çíà÷åíèÿ ñîäåðaeàíèÿ îñòàòî÷íûõ îð-ãàíè÷åñêèõ ðàñòâîðèòåëåé U(X R ) èñïîëüçóåòñÿ ôîðìóëà (17) [24]:…”

Section: ðàñ÷åò êîìáèíèðîâàííîé íåîïðåäåëåííîñòè U(x Ressol ) çíà÷åíèunclassified

“…Êîìáèíèðîâàííàÿ íåîïðåäåëåííîñòü ðåçóëüòàòà îïðåäåëåíèÿ ñîäåðaeàíèÿ âîäû â àòòåñòóåìîé ñóáñòàíöèè êó-ëîíîìåòðè÷åñêèì ìåòîäîì U (X W ) [24]:…”

Section: êóëîíîìåòðè÷åñêèé ìåòîäunclassified

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Об Аттестации Стандартных Образцов В Фармации: Метод Баланса Масс

Épshtein¹

2017

Хим.-фарм. ж.

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В обзоре критически рассмотрены подходы для аттестации субстанций как стандартных образцов (СО) методом баланса масс и ограничения, которые надо учитывать при использовании этого метода. Приведены формулы, необходимые для оценки неопределенности аттестованного значения СО. В том числе предложены отсутствующие в литературе формулы: а) для оценки неопределенности значения содержания органических примесей, получаемых методом нормализации площадей (высот) пиков с поправочными коэффициентами; б) для оценки неопределенности, связанной с пределом обнаружения органических примесей. Приведены рекомендации для корректной аттестации субстанций методом баланса масс.

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