Physicochemical stability and biological activity of Withania somnifera extract under real-time and accelerated storage conditions.
Stability testing at preformulation stages is a crucial part of drug development. We studied physicochemical stability and biological activity of Withania somnifera (ashwagandha) dried root aqueous extract during six months real-time and under accelerated storage conditions. The characteristic constituents of ashwagandha roots include withanolides such as withaferin A and withanolide A. We modified and validated the HPLC-DAD method for quantitative measurement of withanolides and fingerprint analysis. The results suggest a significant decline in withaferin A and withanolide A content under real and accelerated conditions. The HPLC fingerprint analysis showed significant changes in some peaks during real and accelerated storage (> 20 %). We also observed incidences of clump formation and moisture sensitivity (> 10 %) under real-time and accelerated storage conditions. These changes were concurrent with a significant decline in immunomodulatory activity (p < 0.01) during the third month of the accelerated storage. Thus, adequate control of temperature and humidity is important for WSE containing formulations. This study may help in proposing suitable guidance for storage conditions and shelf life of ashwagandha formulations.
Patil
Dada
D
Bioprospecting Laboratory, Interdisciplinary School of Health Sciences, University of Pune, Pune, India.
Gautam
Manish
M
Jadhav
Umesh
U
Mishra
Sanjay
S
Karupothula
Suresh
S
Gairola
Sunil
S
Jadhav
Suresh
S
Patwardhan
Bhushan
B
D000818:Animals; D004355:Drug Stability; D004356:Drug Storage; D004875:Ergosterol / Q000031:analogs & derivatives* / Q000737:chemistry / Q000494:pharmacology; D005260:Female; D007155:Immunologic Factors / Q000737:chemistry* / Q000494:pharmacology; D056747:Immunomodulation / Q000187:drug effects; D007700:Kinetics; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D010316:Particle Size; D010936:Plant Extracts / Q000737:chemistry*; D018517:Plant Roots / Q000737:chemistry; D013995:Time; D032341:Withania / Q000737:chemistry*; D054358:Withanolides
C433551:3-rhamnopyranosyl(1-4)-glucopyranosyl-12-diacetoxy-20-hydroxywitha-5,24-dienolide; D007155:Immunologic Factors; D010936:Plant Extracts; D054358:Withanolides; C009684:withaferin A; D004875:Ergosterol