SCIENTIFIC EVIDENCE FOR STABILITY EVALUATION AND SHELF-LIFE ESTIMATION OF VACHA CHURNA BY USING RP-HPLC

G. NIHARIKA; SYEDA ALISHA MD ISHA ALI; KRISHNAMURTHY BHAT; BASAVARAJ S. HADAPAD; B. S. MUDDUKRISHNA; GUNDAWAR RAVI; MURALIDHAR BALLAL; S. G. VASANTHARAJU

doi:10.22159/ijap.2024v16i4.51117

Authors

G. NIHARIKA Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, (Karnataka) India https://orcid.org/0000-0002-8608-7084
SYEDA ALISHA MD ISHA ALI Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, (Karnataka) India https://orcid.org/0000-0003-2740-5019
KRISHNAMURTHY BHAT Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, (Karnataka) India https://orcid.org/0000-0002-8604-472X
BASAVARAJ S. HADAPAD Division of Ayurveda, Centre for Integrative Medicine and Research, Manipal Academy of Higher Education, Manipal-576104, (Karnataka) India https://orcid.org/0000-0002-9539-7439
B. S. MUDDUKRISHNA Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, (Karnataka) India https://orcid.org/0000-0001-6447-5759
GUNDAWAR RAVI Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, (Karnataka) India https://orcid.org/0000-0002-4041-0560
MURALIDHAR BALLAL General Manager, SDM Ayurveda Pharmacy, Udupi-574118, (Karnataka) India https://orcid.org/0000-0001-9189-1109
S. G. VASANTHARAJU Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, (Karnataka) India https://orcid.org/0000-0002-6253-4935

DOI:

https://doi.org/10.22159/ijap.2024v16i4.51117

Keywords:

Vacha churna, Beta-asarone, Shelf life, Stability studies, Scientific evidence

Abstract

Objective: The concept of shelf life of classical Ayurvedic formulations is clearly defined in the classical literature of Ayurveda. Considering the Ayurveda development and recent gazette notification of 161-B, it is important to evaluate the stability of the Ayurvedic products based on scientific evidence. The study aims to evaluate the stability and estimate the shelf life of Vacha churna by using the marker Beta-asarone. The chemical marker of the Vacha churna has been identified as Beta-asarone.

Methods: A stability-indicating RP-HPLC method has been developed and validated for Beta-asarone. The method utilises a Stationary phase C₁₈ column and a mobile phase composed of acetonitrile and ammonium acetate buffer. Beta-asarone underwent various stress conditions like acid and base hydrolysis, oxidation, temperature and photolytic degradation. The Vacha churna has been stored in a stability chamber for both accelerated and long-term testing. The formulation was taken at specific time intervals and the marker content was analysed using RP-HPLC.

Results: Beta-asarone was eluted at 6.03 min. The linear regression equation was found to be y = 28211x-1349.3 with a R² of 0.9991. Stress studies confirmed the absence of co-eluting peaks and degradants under various stress conditions. Based on the analysis of Beta-asarone marker content, the shelf life of Vacha churna was estimated to be 62.40 mo.

Conclusion: Data from RP-HPLC method and stability studies can be employed for routine commercial stability assessments. Due to the absence of a Pharmacopoeial RP-HPLC method, local Ayurvedic manufacturers can utilise the developed method. The investigated shelf life thus serves as a medium of chemical stability based on the scientific evidence.

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References

Sharma V, Sharma R, Gautam DS, Kuca K, Nepovimova E, Martins N. Role of vacha (Acorus calamus linn.) in neurological and metabolic disorders: evidence from ethnopharmacology, phytochemistry, pharmacology and clinical study. J Clin Med. 2020;9(4):1176. doi: 10.3390/jcm9041176, PMID 32325895.

Mukherjee PK, Kumar V, Mal M, Houghton PJ. Acorus calamus: scientific validation of ayurvedic tradition from natural resources. Pharm Biol. 2007;45(8):651-66. doi: 10.1080/13880200701538724.

Dukkipati S. A review on acorus calamus linn. J Clin Pharm Ther. 2023;4(3):1047.

Rajput SB, Tonge MB, Karuppayil SM. An overview on traditional uses and pharmacological profile of acorus calamus linn. (Sweet flag) and other acorus species. Phytomedicine. 2014;21(3):268-76. doi: 10.1016/j.phymed.2013.09.020, PMID 24200497.

Chauhan A, Semwal DK, Mishra SP, Semwal RB. Ayurvedic research and methodology: present status and future strategies. Ayu. 2015;36(4):364-69. doi: 10.4103/0974-8520.190699, PMID 27833362.

Arunachalam A, Shankar M. Stability studies: a review. Asian J Pharm Anal Med Chem. 2013;1(4):184-95.

OJHA R, Gupta AK, Pandey SK. Shelf life of ayurvedic dosages form: present scenario and need to follow modern paradigm: present scenario of shelf life of ayurvedic dosage forms. J Ayurveda Hol Med (JAHM). 2020;8(6):39-48.

Shweta M, Shivshankar R, Galib, Vaghela DB. Shelf-life evaluation of laghu sutashekhara rasa–a preliminary assessment. J Ayurveda Integr Med. 2020;11(3):213-6. doi: 10.1016/j.jaim.2018.01.007, PMID 30638717.

Gupta V, Jain A, Mb S, Sharma RK. Shelf life of ayurvedic dosage forms in regulatory perspectives. IJAAYUSH. 2017;6(1):360-9. doi: 10.23953/cloud.ijaayush.268.

Government of India. The Gazette of India: Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy (AYUSH) Notification; 2016 Aug 12. Available from: https://main.ayush.gov.in/genericcontent/gazette-notification-gsr-no-789e-dated-12th-august2016-revising-shelf-life-asu-drugs.

Guideline ICH. Validation of analytical procedures Q2. Vol. R1. Geneva, Switzerland: ICH; 2022.

Sam S, Md Isha Ali SA, Muddukrishna BS, Vasantharaju SG. Chemical fingerprinting of piperineand tannic acid in an ayurvedic formulation of dasanakanthi churnam using RP-HPLC. Rasayan J Chem. 2022;15(4):2218-25. doi: 10.31788/RJC.2022.1546984.

De AK, Bera T. Analytical method development, validation, and stability studies by RP-HPLC method for simultaneous estimation of andrographolide and curcumin in co-encapsulated nanostructured lipid carrier drug delivery system. Int J App Pharm. 2021;13(5):73-86, doi: 10.22159/ijap.2021v13i5.42181.

Mishra S, Sarker K, Ghosh A, Saha A, Sen S. A validated stability indicating RP-HPLC method for estimation of avapritinib in bulk and tablet dosage form. Int J App Pharm. 2022;14(2):95-101. doi: 10.22159/ijap.2022v14i2.43432.

Gandhi SV, Jagtap M. Development and validation of stability indicating hptlc method for determination of iguratimod in bulk and pharmaceutical dosage form. Int J Pharm Pharm Sci. 2022;14(11):31-6. doi: 10.22159/ijpps.2022v14i11.45705.

Lakshmi AJ, Abhishek K, Priyanka YL, Balaji PV, Ashritha N. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of aclidinium bromide and formoterol fumarate in bulk and inhaler formulation. Int J Curr Pharm Sci 2022;14(5):13-9. doi: 10.22159/ijcpr.2022v14i5.1973.

Guideline ICH. Stability testing of new drug substances and products. Current Step. 2003 Feb;4:1-24.

Determination of shelf life of four herbal medicinal products using high-performance liquid chromatography analyses of markers and the systat sigmaplot software. J App Pharm Sci. 2020;10(6):72-80. doi: 10.7324/JAPS.2020.10610.

Ashokan A, Shincymol VV, Ansary PY, Ommen SM. HPTLC fingerprinting profile of vacha (Acorus calamus linn.). Int Res J Ayurveda Yoga. 2023;06(12):45-9. doi: 10.47223/IRJAY.2023.61207.

Vijayakumar KB, Bannimath G, Koganti VS, Iyer VB. Gas chromatographic method for analysis β-asarone in rhizome extracts of acorus calamus and their microbiological evaluation. Pharm Methods. 2016;7(2):121-6. doi: 10.5530/phm.2016.7.18.

Hermes L, Romermann J, Cramer B, Esselen M. Quantitative analysis of β-asarone derivatives in acorus calamus and herbal food products by HPLC-MS/MS. J Agric Food Chem. 2021;69(2):776-82. doi: 10.1021/acs.jafc.0c05513, PMID 33410326.

Shailajan S, Menon S, Swar G, Singh D, Nair S. Estimation and quantitation of β-asarone from acorus calamus rhizome and its formulations using validated RP-HPLC method. Pharm Meth. 2015;6(2):94-9. doi: 10.5530/phm.2015.6.13.

Mythili MN, Immanuel SC, Rajasekharan PE, Rajasekaran C, Tharachand C, Rao VK. HPLC profiling of B-Asarone content and cytogenetic studies of medicinally important Indian acorus calamus l. Accessions. Int J Pharm Sci Rev Res. 2013;22:73-8.

Shibin Felix P, Aswathy Anand A, Decruse SW, Radha RK. Quantification of β-asarone content in Acorus calamus l., an aromatic medicinal plant from the Western ghats. J Pharmacogn Phytochem. 2023;12(5);12. doi: 10.22271/phyto.2023.i5e.14754:433-9.