Journal of Drug Research in Ayurvedic Sciences

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VOLUME 4 , ISSUE 4 ( October-December, 2019 ) > List of Articles

Original Article

Shelf Life Evaluation of Shirishavaleha and its Granules: A Preliminary Study

Dilip Kumar D Prajapati, Prashant Bedarkar

Keywords : Khanda Sharkara, Shelf life, Shirishavaleha,Accelerated stability

Citation Information : Prajapati DK, Bedarkar P. Shelf Life Evaluation of Shirishavaleha and its Granules: A Preliminary Study. J Drug Res Ayurvedic Sci 2019; 4 (4):157-167.

DOI: 10.5005/jdras-10059-0081

License: CC BY-NC 4.0

Published Online: 00-12-2019

Copyright Statement:  Copyright © 2019; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Background: Shelf life is the length of time, after which all substances starts to degrade in their qualities and become unsuitable for consumption or sale. Every product has definite shelf life, which depends on various physical, chemical, environmental, and biological factors. Shelf life of various compound formulations was clarified in the classical text. So there is a need to revalidate and establish the shelf life of individual formulation. As the Government of India made it mandatory to display in the labels the shelf life of all products, it becomes essential to evaluate the actual shelf life of individual products by following the specified guidelines. Aim: To evaluate the shelf life of Shirishavaleha (SHA) and its granules prepared with Khanda Sharkara through accelerated stability parameters. Materials and methods: Physicochemical parameters of SHA and Shirishavaleha granules (SHG) were calculated by maintaining 40°C ± 2°C temperature and 75 ± 5% relative humidity at the intervals of 0, 1, 3, and 6 months. Based upon the observations, intercept, slope, 10% degradation of the sample, and finally the shelf life were calculated. Results: Accelerated stability study reveals the shelf life of SHA as 5.9 years, while that of the granules as 5.3 years. Similar Rf values obtained in high-performance thin-layer chromatography (HPTLC) analysis of both samples initially and after 6 months showed minimum deterioration of the product. Microbial count and heavy metals were below the permissible limits in both the samples. Conclusion: Guidelines specified in the Drugs and Cosmetics Act, 1940, mentions 3 years as the shelf life of Avalehas and granules. This time period is general, and different formulations may have different shelf lives based upon the factors such as their composition, etc. The samples tested in the current study, i.e., SHA and SHG, are found to have a shelf life of 5.9 and 5.3 years, respectively, through accelerated stability study that are almost double the average time specified in the guidelines.


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  1. Kommanaboyina B, Rhodes CT. Trends in stability testing, with emphasis on stability during distribution and storage. Drug Dev Ind Pharm 1999;25(7):857–868. DOI: 10.1081/ddc-100102246.
  2. Pt. Parashuram Shastri Vidyasagar editor. 1st ed. Sharangadhara Samhita of Pt. Sharangdhra with Ashamalla Dipika and Gudhartha Dipika commentary of Kashiram, Poorva Khanda ch. 1, Verse 51. Varanasi: Chaukhambha Surbharati Prakashan; 2013. p. 13.
  3. Shaligram GV editor. 1st ed. Vangasen Samhita of Vangasena, Jwara Chikitsa, ch. 1, Verse 810, Mumbai: Khemraj Shrikrishnadass Publication; 2003. p. 73.
  4. Parashuram Shastri Vidyasagar editor. 1st ed. Sharangadhara Samhita of Pt. Sharangdhra with Ashamalla Dipika and Gudhartha Dipika commentary of Kashiram, Poorva Khanda ch. 1, Verse 52, Varanasi: Chaukhambha Surbharati Prakashan; 2013. p. 13.
  5. Anonymous. Yogaratnakara, Jwara Chikitsha, edited by Shastri L. 1st ed. Varanasi: Chaukhamba Sanskrita Samsthana; 2005. p. 203.
  6. Drugs and Cosmetics Rule 1945. Part-XVII 161-B, Ministry of Health and Welfare, Govt. of India. p. 192.
  7. The Gazette of Govt. of India on Drugs and Cosmetics Act, published on August 2016.
  8. Mishra S, editor. 1st ed. Bhaishjya Ratnavali of Kaviraj Govind Das Sen, Vishrogadhikara, ch. 72, verse 71–73. Varanasi: Chaukhambha Bidyabhavan; 2015. p. 1106.
  9. Anonymous. ICH Harmonised Tripartite Guideline. Stability testing of new drug substances and products – Q1A (R2); 2003.
  10. Anonymous. Ayurvedic Pharmacopoeia of India (API). Part II, vol. II, Appendix 2:63 (3.3), 1st ed. New Delhi: Govt. of India, Ministry of Health and Family Welfare, Dept. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy; 2001.
  11. Anonymous. Ayurvedic Pharmacopoeia of India (API). Part II, vol. II, Appendix 2:11 (2.2.3), 1st ed. New Delhi: Govt. of India, Ministry of Health and Family Welfare, Dept. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy; 2001.
  12. Anonymous. Ayurvedic Pharmacopoeia of India (API). Part II, vol. II, Appendix 2:12 (2.2.8), 1st ed. New Delhi: Govt. of India, Ministry of Health and Family Welfare, Dept. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy; 2001.
  13. Anonymous. Ayurvedic Pharmacopoeia of India (API). Part II, vol. II, Appendix 2:11 (2.2.7), 1st ed. New Delhi: Govt. of India, Ministry of Health and Family Welfare, Dept. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy; 2001.
  14. Anonymous. Ayurvedic Pharmacopoeia of India (API). Part II, vol. II, Appendix 2:18 (2.2.16), 1st ed. New Delhi: Govt. of India, Ministry of Health and Family Welfare, Dept. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy; 2001.
  15. Anonymous. Ayurvedic Pharmacopoeia of India (API). Part II, vol. II, Appendix 2:18 (2.2.18), 1st ed. New Delhi: Govt. of India, Ministry of Health and Family Welfare, Dept. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy; 2001.
  16. Anonymous. Ayurvedic Pharmacopoeia of India (API). Part II, vol. II, Appendix 2:18 (2.2.15), 1st ed. New Delhi: Govt. of India, Ministry of Health and Family Welfare, Dept. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy; 2001.
  17. Anonymous, The Ayurvedic Pharmacopoeia of India. 1st ed. Govt. of India: Ministry of Health and Family Welfare; Part II, vol. I; 2007: Appendix 2, (2.3.3). p. 153.
  18. Kaur H, Galib R, Prajapati PK. Shelf life evaluation of Shirishavaleha: a preliminary study. BLDE Univ J Health Sci 2016;1(2):120–124. DOI: 10.4103/2468-838X.196099.
  19. Khemuka N, Galib R, Patgiri BJ, et al. Shelf-life evaluation of Kamsa haritaki avaleha and its granules: a preliminary study. Anc Sci Life 2015;35(2):96–100. DOI: 10.4103/0257-7941.171670.
  20. Ankit P, Galib, Patgiri BJ, et al. Shelf-life evaluation of Vasavaleha and its granules – a preliminary study. Sri Lanka J Indigenous Med 2014;4(1):242–245.
  21. Ankit G, Mandeep J, Prajapati PK. Shelf-life of Ayurvedic dosage form-traditional view, current status and prospective need. Indian J Tradit Know 2011;10(4):672–677.
  22. https://en.wikipedia.org/wiki/Sugar_candy, accessed on date 07/01/2018.
  23. Ergun R, Lietha R, Hartel RW. Moisture and shelf life in sugar confections. Crit Rev Food Sci Nutr 2010;50(2):162–192. DOI: 10.1080/10408390802248833.
  24. Bureau of Indian Standard IS13952:1990 Cane Gur (Jaggery)- Specification, Oct-2013.
  25. https://en.wikipedia.org/wiki/Inverted_sugar_syrup#Shelf_life, accessed on date 03/01/2018.
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