WHO prescribed shelf life assessment of Syzygium cumini extract through chromatographic and biological activity analyses

Jasmeen Kaur; Gulshan Bansal

doi:10.1016/j.jaim.2019.01.003

WHO prescribed shelf life assessment of Syzygium cumini extract through chromatographic and biological activity analyses

J Ayurveda Integr Med. 2020 Jul-Sep;11(3):294-300. doi: 10.1016/j.jaim.2019.01.003. Epub 2019 Nov 20.

Authors

Jasmeen Kaur¹, Gulshan Bansal²

Affiliations

¹ Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, 147002, India.
² Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, 147002, India. Electronic address: gulshanbansal@rediffmail.com.

Abstract

Background: Regulatory guidelines recommend shelf life of herbal products to be established through systematic stability studies.

Objective: The study was designed to establish shelf life of Syzygium cumini extract through accelerated and long-term stability testing as per WHO guidelines.

Material and methods: The extract was stored under accelerated (40°C/75 %RH) and long-term (25°C/60 %RH) stability conditions for 6 and 30 months, respectively. Samples were withdrawn at periodic intervals and analysed through two validated HPLC-UV methods (I and II) for fingerprint and quantitative analysis of markers. Antidiabetic activity of control and stability samples was evaluated by α-glucosidase inhibitory model.

Results: Method I generated a well resolved fingerprint of the control sample that was found to contain gallic acid (GA, 1.45 % w/w) and ellagic acid (EA, 3.97 % w/w). The content of GA did not change under both the stability conditions, but that of EA varied insignificantly (3.97-4.77 % w/w) under long-term conditions up to 24 months and subsequently decrease to 3.15 % w/w after 30 months. There was no visible change in LC-UV fingerprint of any stability sample with respect to control. α-Glucosidase inhibitory activity of all stability samples also remained unaltered as compared to control sample (IC₅₀ 1.48 mg/mL). GA and EA did not elicit any activity at the concentrations present in the extract.

Conclusion: Phytochemical composition and antidiabetic efficacy of S. cumini extract remain unchanged during its storage under both accelerated and long-term stability conditions, which suggest its shelf life to be 30 months. Also, GA and EA are not appropriate anti-diabetic markers.

Keywords: Antidiabetic; Ellagic acid; Gallic acid; Glucosidase; Stability; Syzygium cumini.