DETERMINATION OF SHELF LIFE OF AN AYURVEDIC FORMULATION KAISHORA GUGGULU USING RP-HPLC ANALYSIS OF CHEMICAL MARKERS

Syeda Alisha Md Isha Ali, Niharika Gaddam, Krishnamurthy Bhat, B. S. Muddukrishna, Murlidhar Ballal, Sandeep G. Datarkar, S. G. Vasantharaju

Research output: Contribution to journalArticlepeer-review

Abstract

A new RP-HPLC stability-indicating assay method was developed and stability studies were conducted to determine the shelf life of Kaishora Guggulu. Magnoflorine, Palmatine, and Berberine form the chief chemical markers for the chemical fingerprinting of Kaishora Guggulu. Separation was performed using RP-HPLC equipped with a PDA detector at wavelengths Magnoflorine (231nm), Palmatine (271nm), and Berberine (280nm). The strategy applied for the determination of marker content in the formulation was under prescribed ICH storage conditions of temperature and humidity at specific time points. Stability studies hence were conducted at accelerated conditions at time points (0, 1, 3, and 6 months) and long-term conditions at time points (0, 6, 9, and 12 months). A stability-indicating RP-HPLC method is developed by performing stress studies on markers such as acid and alkaline hydrolysis, photolytic, oxidative, and thermal degradation. Palmatine, Berberine, and Magnoflorine were effectively separated and detected using a photodiode array detector. The stability indicating RP-HPLC assay method was validated and employed for the stability studies. The marker content analysis at the prescribed time period elicited a shelf life of 27.32, 21.37, and 11.29 months considering the markers Magnoflorine, Palmatine, and Berberine. Thus the RP-HPLC method and stability studies data can be utilized for routine commercial stability studies. No pharmacopoeial RP-HPLC method is available so developed this method for laboratory use by local Ayurvedic manufacturers.

Original languageEnglish
Pages (from-to)1509-1515
Number of pages7
JournalRasayan Journal of Chemistry
Volume16
Issue number3
DOIs
Publication statusPublished - 01-07-2023

All Science Journal Classification (ASJC) codes

  • General Chemistry
  • Biochemistry
  • General Chemical Engineering
  • General Energy
  • Pharmacology, Toxicology and Pharmaceutics(all)

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