36 / 41
Page 80
conferenceseries
.com
Volume 5, Issue 5 (Suppl)
Nat Prod Chem Res
ISSN: 2329-6836 NPCR, an open access journal
Pharmacognosy 2017
July 24-25, 2017
July 24-25, 2017 Melbourne, Australia
5
th
International Conference and Exhibition on
Pharmacognosy, Phytochemistry
& Natural Products
Stability testing of botanicals: An exploratory study
Jadhav U S
1
, Patwardhan B K
2
, Mahadik K R
3
and Yadav A V
3
1
Gourishankar Institute of Pharmaceutical Education & Research, India
2
Interdisciplinary School of Health Sciences, India
3
Poona College of Pharmacy, India
Introduction:
The role of herbs as drugs, neutraceuticals and dietary supplements is gaining popularity. There have been several
examples of poor quality of these products. The formulation and development of botanicals is challenging due to their complex
physical and chemical properties. Stability study of herbals is important as instability modifies three important attributes of product
i.e., quality, safety and efficacy. Botanicals mentioned under Ayurveda are receiving attention globally. Scientifically validated and
technologically standardized botanicals are currently needed for global market.
Emblica officinalis
is mentioned under Ayurveda as
a Rasayana drug and is present in many formulations. In recent years, much success has been obtained in documentation, ensuring
contaminants limits, safety and standardization. However, the stability testing has not been adequately addressed. The present study
was done as per WHO and ICH guidance.
Objectives:
To develop the analytical method for gallic acid estimation using HPTLC and validation as per ICH guidelines, to
elucidate the physical, chemical, pharmaceutical and biological attributes of the Amla extract with respect to real and accelerated
storage conditions and to establish shelf life of spray dried Amla extract with respect to storage conditions and re-test periods.
Methodology:
Mobile phase optimization- Mobile phase consisting of toluene:Ethyl acetate: Formic acid in the ratio of (4.0:5.5:0.5,
v/v/v/v) was optimized and good resolution with Rf value of 0.36±0.02 for gallic acid was obtained when densitometry scanning was
performed at 277 nm.
Method Validation:
The optimized method validated as per ICH guidelines.
Results:
Pharmaceutical properties were measured i.e., particle size and flow, extract showed poor free flowing properties and very
moisture sensitive. It showed significant change in physical (moisture content 4-7% at real with respect to 4-11% at accelerated).
Significant change in form was also observed at real time (clumps) and accelerated (cake) at end of six months. Extract when stored
at real time showed significant change in physical (moisture content, form) and chemical (peak areas at Rf-0.47) and pharmaceutical
(flow and compressibility) properties on 6 months storage. In accelerated conditions, these changes were seen at 1-3 months of
storage. Biological stability of extract was studied using DPPH assay.
Conclusion:
No significant change in activity was found at 6 months storage at room and accelerated storage. This suggests that extract
re-test period should be within 6 months and proper storage conditions needs to be optimized with respect to container and temperature.
umeshjadhav12@rediffmail.comNat Prod Chem Res 2017, 5:5 (Suppl)
DOI: 10.4172/2329-6836-C1-017