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Method Development and Stability Stu...

Pradhan, Sharvari Sainath.

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Method Development and Stability Study to Determine Amount of Genistein Present in Formulation Intended for Use in Pediatric Asthma.

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Method Development and Stability Study to Determine Amount of Genistein Present in Formulation Intended for Use in Pediatric Asthma./
作者:	Pradhan, Sharvari Sainath.
出版者:	Ann Arbor : ProQuest Dissertations & Theses, : 2023,
面頁冊數:	53 p.
附註:	Source: Masters Abstracts International, Volume: 85-03.
Contained By:	Masters Abstracts International85-03.
標題:	Pharmaceutical sciences. -
電子資源:	https://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=30633018
ISBN:	9798380150538

Method Development and Stability Study to Determine Amount of Genistein Present in Formulation Intended for Use in Pediatric Asthma.
Pradhan, Sharvari Sainath.

Method Development and Stability Study to Determine Amount of Genistein Present in Formulation Intended for Use in Pediatric Asthma. - Ann Arbor : ProQuest Dissertations & Theses, 2023 - 53 p.

Source: Masters Abstracts International, Volume: 85-03.

Thesis (M.S.)--University of Colorado Denver, Anschutz Medical Campus, 2023.

Purpose: This study presents method development and stability study to determine amount of genistein present in formulation and packed in ConiSnap{phono}{mlrhring} capsules. Methods: The analytical method developed for this study was High-performance liquid chromatography (HPLC) with ultraviolet (UV) detection. The HPLC-UV method was validated as per ICH guidelines. ConiSnap{phono}{mlrhring} capsules were stored at ambient temperature in amber plastic bottles with child resistant caps. For preliminary stability study, samples were pulled on days 14, 28, 42 and 56. Before sample preparation, two high dose capsules were packed in 2ml centrifuge tubes and differentiated into room temperature sample (placed on bench top) and frozen sample (kept in -80{CE}{BF}C freezer for {acute}{89}{AElig} 4 hours). Frozen sample was allowed to reach room temperature before analysis. Same procedure was followed for low dose capsules. For final sample preparation, capsules were opened, and formulation powder was weighed into scintillation vials, diluted with dimethylsulfoxide:methanol (7:3 v/v) such that samples contained an estimated 25 {CE}{ohorn}M concentration of genistin (n=4). Same was followed to acquire 25 {CE}{ohorn}M concentration for genistein samples (n=4). For long term stability, capsules stored at room temperature for 12 months were analyzed using same dilution procedure. Forced degradation studies were performed under basic and acidic conditions to{A0}prove the stability indicating nature of the developed method. Results: For method validation, system suitability criteria were met. Limit of quantitation was 0.04 {CE}{ohorn}M and limit of detection was 0.02 {CE}{ohorn}M for both genistin and genistein. Intra-day variation was < 5% and inter-day variation was < 2% for both genistin and genistein. For preliminary stability study, the percent recovery of total molar genistein equivalents for all sample points fell within the expected range of 90%-110%. The percent recovery of total molar genistein equivalents for long term stability samples was found to be 104.2% with a SD of 2.6%. Degradation products (detected by UV) were formed under basic conditions with heat as catalyst. Conclusion: The HPLC-UV method met all requirements of analytical method validation. Genistein packed in ConiSnap{phono}{mlrhring} capsules and exposed to freeze thaw conditions was stable for 8 weeks. Formulation packed in capsules stored at room temperature was stable for a minimum of one year.{A0}

ISBN: 9798380150538Subjects--Topical Terms:

3173021
Pharmaceutical sciences.
Subjects--Index Terms:

Pediatric asthma

Method Development and Stability Study to Determine Amount of Genistein Present in Formulation Intended for Use in Pediatric Asthma.
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300 $a 53 p.
500 $a Source: Masters Abstracts International, Volume: 85-03.
500 $a Advisor: Kroll, David;Rice, Peter J.
502 $a Thesis (M.S.)--University of Colorado Denver, Anschutz Medical Campus, 2023.
520 $a Purpose: This study presents method development and stability study to determine amount of genistein present in formulation and packed in ConiSnap{phono}{mlrhring} capsules. Methods: The analytical method developed for this study was High-performance liquid chromatography (HPLC) with ultraviolet (UV) detection. The HPLC-UV method was validated as per ICH guidelines. ConiSnap{phono}{mlrhring} capsules were stored at ambient temperature in amber plastic bottles with child resistant caps. For preliminary stability study, samples were pulled on days 14, 28, 42 and 56. Before sample preparation, two high dose capsules were packed in 2ml centrifuge tubes and differentiated into room temperature sample (placed on bench top) and frozen sample (kept in -80{CE}{BF}C freezer for {acute}{89}{AElig} 4 hours). Frozen sample was allowed to reach room temperature before analysis. Same procedure was followed for low dose capsules. For final sample preparation, capsules were opened, and formulation powder was weighed into scintillation vials, diluted with dimethylsulfoxide:methanol (7:3 v/v) such that samples contained an estimated 25 {CE}{ohorn}M concentration of genistin (n=4). Same was followed to acquire 25 {CE}{ohorn}M concentration for genistein samples (n=4). For long term stability, capsules stored at room temperature for 12 months were analyzed using same dilution procedure. Forced degradation studies were performed under basic and acidic conditions to{A0}prove the stability indicating nature of the developed method. Results: For method validation, system suitability criteria were met. Limit of quantitation was 0.04 {CE}{ohorn}M and limit of detection was 0.02 {CE}{ohorn}M for both genistin and genistein. Intra-day variation was < 5% and inter-day variation was < 2% for both genistin and genistein. For preliminary stability study, the percent recovery of total molar genistein equivalents for all sample points fell within the expected range of 90%-110%. The percent recovery of total molar genistein equivalents for long term stability samples was found to be 104.2% with a SD of 2.6%. Degradation products (detected by UV) were formed under basic conditions with heat as catalyst. Conclusion: The HPLC-UV method met all requirements of analytical method validation. Genistein packed in ConiSnap{phono}{mlrhring} capsules and exposed to freeze thaw conditions was stable for 8 weeks. Formulation packed in capsules stored at room temperature was stable for a minimum of one year.{A0}
590 $a School code: 1639.
650 4 $a Pharmaceutical sciences. $3 3173021
650 4 $a Pedagogy. $3 2122828
650 4 $a Pharmacology. $3 634543
653 $a Pediatric asthma
653 $a Ultraviolet detection
653 $a Plastic bottles
653 $a Dilution procedure
653 $a Frozen samples
690 $a 0572
690 $a 0456
690 $a 0419
710 2 $a University of Colorado Denver, Anschutz Medical Campus. $b Pharmaceutical Sciences. $3 3768979
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793 $a English
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