STANDARDISATION AND HPTLC METHOD DEVELOPMENT OF MARKETED AYURVEDIC FORMULATION – BALARISHTA

Authors

  • Tabassum A. Khan Department of Pharmaceutical Chemistry, SVKM’s Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, India
  • Anjali K. Gohel
  • Rashmi Mallya

Abstract

Objective: The present study aims to standardize four marketed brands of Balarishta, an Ayurvedic formulation viz. Baidyanath-Balarishta (BB), Dabur-Balarishta (DB), Zandu-Balarishta (ZB) and Nagarjuna-Balarishta (NB) with respect to their physicochemical (organoleptic properties, pH, specific gravity, total solid content, ethanol content, reducing and non-reducing sugar content), phytochemical and microbial parameters (total bacterial count, total fungal count and test for specific pathogens viz. P. aeruginosa, E. coli and S. aureus). It also aims to develop and validate a new highperformance thin layer chromatography (HPTLC) method for simultaneous determination of three major phytoconstituents present in Balarishta viz. withaferin A, gallic acid and ephedrine.

Methods: ‘Protocol for testing Ayurveda, Siddha and Unani medicines' was used as a reference for conducting standardization experiments. HPTLC method was developed on Camag Linomat-5 using silica gel 60 GF254 as the stationary phase and Toluene: Chloroform: n-propanol: Ethanol: Formic acid (6: 3: 1: 2: 1, v/v/v/v/v) as the mobile phase. The analytical method validation studies were performed as per International Conference on Harmonization-Quality (ICH-Q2 (R1)) guidelines.

Results: The results of standardisation tests obtained were compared with specifications mentioned in ‘Ayurvedic Pharmacopoeia of India 2008 Volume 2, Part 2' and a comparative data of each Balarishta formulation was generated for all the quality control parameters performed. A new, accurate, precise and robust HPTLC method was successfully developed with Retardation factor (Rf) of 0.17±0.02, 0.35±0.01 and 0.54±0.02 for ephedrine, gallic acid and withaferin A respectively.

Conclusion: The results of this research work will serve as a valuable quality tool for routine quality control analysis of Balarishta formulations.

Keywords: Balarishta, Standardisation, Withaferin A, Gallic acid, Ephedrine and HPTLC.

Downloads

Download data is not yet available.

References

Rastogi S. Building bridges between Ayurveda and modern science. Int J Ayurveda Res 2001;1:41-2.

Kochhar SL. Tropical crops: A textbook of economy botany. 2nd ed. London: Macmillan Pub Ltd; 1981. p. 268–71.

Legal status of traditional medicine, complementary/ alternative medicine: a worldwide review. Geneva: World Health Organization; 2001.

Yadav NP, Dixit VK. Recent approaches in herbal drug standardisation. Int J Integr Biol 2008;2:195-203.

Farnsworth NR, Akerele O, Bingel AS, Soejarto DD, Guo ZG. Medicinal plants in therapy. Bull World Health Organization 1985;63:965-81.

Pushpangadan. WHO guidelines on good agricultural collection practices (GACP) for medicinal plants. Indian J Med Res; 2004.

Sekar S, Mariappan S. Traditionally fermented biomedicines, arishtas and asavas from Ayurveda. Indian J Traditional Knowledge 2008;7:548-56.

Hebbar JV. Ayurvedic medicine information. Available from:

http://ayurmedinfo.com/2011/06/29/balarishta-uses-side-effects-dose-and-side-effects/. [Last accessed on 20 Oct 2015].

The Ayurvedic Pharmacopoeia of India. Volume-2. Part-2. Department of Ayush, Ministry of Health, India. 2008. Available from: http://herbalnet. healthrepository.org/bitstream/ 123456789/2076/8/MONOGRAPHS-%20API%20Part%202% 20VOL-2.pdf. [Last accessed on 20 Oct 2015].

Protocol for testing ayurveda, siddha and unani medicines. Dept. of AYUSH, Ministry of Health and Family Welfare, Ghaziabad. http://www. researchgate.net/ publication/ 224944109_Protocol_for_Testing_of_ayurvedic_Siddha_and_Unani_medicines. [Last accessed on 20 Oct 2015].

Indian Pharmacopoeia. Govt of India. Ministry of Health and Family Welfare. 7th ed. Vol. 1; 2014. p. 116-7.

Lane JH, Eynon L. Volumetric determination of reducing sugars by means of Fehling's solution with methylene blue as internal indicator. J Soc Chem Ind London 1923;2:32-6.

Khandelwal KR. Preliminary phytochemical screening. Practical Pharmacognosy-Techniques and experiments. 14th ed. Nirali Prakashan; 2005. p. 149-53.

ICH Harmonised Tripartite Guideline-Validation of Analytical Procedures: Text and Methodology Q2 (R1). Available from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf. [Last accessed on 20 Oct 2015].

Annadurai V, Subbiah M, Soundarapandian S. Tracking the organoleptic and biochemical changes in the Ayurvedic polyherbal and native fermented traditional medicines: Balarishta and Chandanasava. Int J Pharm Pharm Sci 2014;6:521-6.

Rajalakshmy MR, Sindhu A. Preliminary phytochemical screening and antioxidant activity of an ayurvedic formulation: balarishtam. Int J Res Ayur Pharm 2011;2:1645-7.

Vador N, Vador B, Hole R. Simple spectrophotometric methods for standardizing Ayurvedic formulation. Indian J Pharm Sci 2012;74:161-3.

Published

01-03-2016

How to Cite

Khan, T. A., A. K. Gohel, and R. Mallya. “STANDARDISATION AND HPTLC METHOD DEVELOPMENT OF MARKETED AYURVEDIC FORMULATION – BALARISHTA”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 8, no. 3, Mar. 2016, pp. 201-9, https://www.innovareacademics.in/journals/index.php/ijpps/article/view/10028.

Issue

Section

Original Article(s)