國立虎尾科技大學 |

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

Record Type:	Language materials, manuscript : Monograph/item
Title/Author:	Method Development and Stability Study to Determine Amount of Genistein Present in Formulation Intended for Use in Pediatric Asthma./
Author:	Pradhan, Sharvari Sainath.
Description:	1 online resource (53 pages)
Notes:	Source: Masters Abstracts International, Volume: 85-03.
Contained By:	Masters Abstracts International85-03.
Subject:	Pharmaceutical sciences. -
Online resource:	click for full text (PQDT)
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. - 1 online resource (53 pages)

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

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

Includes bibliographical references

Purpose: This study presents method development and stability study to determine amount of genistein present in formulation and packed in ConiSnap® 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® 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 -80οC freezer for ≥ 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 μM concentration of genistin (n=4). Same was followed to acquire 25 μM 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 prove the stability indicating nature of the developed method. Results: For method validation, system suitability criteria were met. Limit of quantitation was 0.04 μM and limit of detection was 0.02 μM 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® 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.

Electronic reproduction.
Ann Arbor, Mich. :
ProQuest,
2024

Mode of access: World Wide Web

ISBN: 9798380150538Subjects--Topical Terms:

1180569
Pharmaceutical sciences.
Subjects--Index Terms:

Pediatric asthmaIndex Terms--Genre/Form:

554714
Electronic books.

Method Development and Stability Study to Determine Amount of Genistein Present in Formulation Intended for Use in Pediatric Asthma.
LDR:03852ntm a22003977 4500 001 1147109
005 20240909062217.5
006 m o d
007 cr bn ---uuuuu
008 250605s2023 xx obm 000 0 eng d
020 $a 9798380150538
035 $a (MiAaPQ)AAI30633018
035 $a AAI30633018
040 $a MiAaPQ $b eng $c MiAaPQ $d NTU
100 1 $a Pradhan, Sharvari Sainath. $3 1472755
245 1 0 $a Method Development and Stability Study to Determine Amount of Genistein Present in Formulation Intended for Use in Pediatric Asthma.
264 0 $c 2023
300 $a 1 online resource (53 pages)
336 $a text $b txt $2 rdacontent
337 $a computer $b c $2 rdamedia
338 $a online resource $b cr $2 rdacarrier
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.
504 $a Includes bibliographical references
520 $a Purpose: This study presents method development and stability study to determine amount of genistein present in formulation and packed in ConiSnap® 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® 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 -80οC freezer for ≥ 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 μM concentration of genistin (n=4). Same was followed to acquire 25 μM 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 prove the stability indicating nature of the developed method. Results: For method validation, system suitability criteria were met. Limit of quantitation was 0.04 μM and limit of detection was 0.02 μM 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® 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.
533 $a Electronic reproduction. $b Ann Arbor, Mich. : $c ProQuest, $d 2024
538 $a Mode of access: World Wide Web
650 4 $a Pharmaceutical sciences. $3 1180569
650 4 $a Pedagogy. $3 1148703
650 4 $a Pharmacology. $3 583819
653 $a Pediatric asthma
653 $a Ultraviolet detection
653 $a Plastic bottles
653 $a Dilution procedure
653 $a Frozen samples
655 7 $a Electronic books. $2 local $3 554714
690 $a 0572
690 $a 0456
690 $a 0419
710 2 $a ProQuest Information and Learning Co. $3 1178819
710 2 $a University of Colorado Denver, Anschutz Medical Campus. $b Pharmaceutical Sciences. $3 1472756
773 0 $t Masters Abstracts International $g 85-03.
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=30633018 $z click for full text (PQDT)