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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 2  |  Issue : 2  |  Page : 73-77

Stability study of sarpagandha ghana vati - A preliminary evaluation


1 Private Practitioner, Bhagwant Ayurvedic College and Bhagwant Hospital, Muzaffarnagar, Uttar Pradesh, India
2 Department of Rasa Shastra and Bhaishajya Kalpana, Bhagwant Ayurvedic College and Bhagwant Hospital, Muzaffarnagar, Uttar Pradesh, India
3 Department of Rasa Shastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, India

Date of Submission16-May-2021
Date of Decision29-Jul-2021
Date of Acceptance25-Sep-2021
Date of Web Publication29-Nov-2021

Correspondence Address:
Punam Aggarwal
Assistant Professor, Bhagwant Ayurvedic College and Bhagwant Hospital, Muzaffarnagar, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijaim.ijaim_17_21

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  Abstract 


Background: Shelf life is the time period until a product retains its therapeutic attributes and fit for use, consumption, or sale. Every product in this universe has definite shelf life. In Ayurveda texts, shelf life is referred as Saviryata avadhi that is defined as the time period during which the potency (Virya) of any drug remains unaffected. As per the regulations of Government of India, it is mandatory to mention shelf life on all marketed products on their labels. Sarpagandha ghana vati is an important formulation being used in Ayurvedic therapeutics; however, its shelf life is not reported till date. Aims and Objectives: The aim of this study was to evaluate the shelf life of Sarpagandha ghana vati through accelerated stability study. Materials and Methods: The formulation was prepared using authentic raw material and by following classical guidelines in the departmental laboratory. Shelf life was evaluated by analyzing changes in physicochemical profiles of the product after keeping it at specific temperature (40 ± 2°C) and relative humidity (75 ± 5%). Analysis was carried out at the intervals of 1, 3, and 6 months. Average 10% degradation time was calculated and extrapolated to find the shelf life as per the International Conference on Harmonization guidelines. Results and Conclusion: The shelf life of Sarpagandha ghana vati was found to be 16 months, which is higher than the average time period mentioned in the classical literature and lower than the time specified in the Gazette of India.

Keywords: Sarpagandha ghana vati, Saviryata avadhi, Shelf life, Stability


How to cite this article:
Bajiya M, Aggarwal P, Galib R, Prajapati PK, Yadav PR. Stability study of sarpagandha ghana vati - A preliminary evaluation. Indian J Ayurveda lntegr Med 2021;2:73-7

How to cite this URL:
Bajiya M, Aggarwal P, Galib R, Prajapati PK, Yadav PR. Stability study of sarpagandha ghana vati - A preliminary evaluation. Indian J Ayurveda lntegr Med [serial online] 2021 [cited 2022 Jan 19];2:73-7. Available from: http://www.ijaim.com/text.asp?2021/2/2/73/331488




  Introduction Top


A common belief prevailing in people is that Ayurvedic drugs have no expiry period. On contrary to this, shelf life is mentioned in most of the Ayurvedic texts. A term, Saviryata avadhi, comparable to shelf life is mentioned that refers to the time period during which the Virya (therapeutic potency) of any drug remains unaffected.[1] Texts such as Vangasena,[2] Sharangadhara samhita,[1] and Yogaratnakara[3] have specifically mentioned shelf life for different Ayurvedic dosage forms. The shelf life of any drug can be considered up to the period till it retains the specified qualities. In conventional science, stability is defined as “The capability of a particular dosage form, in a specific container or closure system, to remain with its physical, chemical, microbiological, therapeutic, and toxicological specifications.” The International Conference on Harmonization (ICH) also defines shelf life as the time period during which a product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.[4] These definitions lead to an inference that the time period could be different for different drugs and formulations. Thus, it becomes essential to evaluate the exact shelf life of individual formulations. As Sarpagandha ghana vati is an important formulation being widely used by many of the traditional physicians and as its stability profile is not available; an attempt has been made to evaluate the same by following accelerated stability protocol.


  Materials and Methods Top


Collection of raw materials

Sarpagandha ghana vati is a polyherbal Ayurvedic formulation [Table 1]. Sarpagandha (Rauwolfia serpentine [L.] Benth. ex Kurz.), Khurasani yavani (Hyoscyamus niger Linn.), Jatamansi (Nardostachys jatamnsi DC.), and Pippali mula (Piper longum Linn.) were procured from the local markets. Certified sample of Bhanga (Cannabis sativa Linn.) in required quantities were provided by the Indian Hemp Association, Dehradun, Uttarakhand.
Table 1: Formulation composition of Sarpagandha ghana vati

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Authentication

All raw drugs were authenticated at NISCAIR, New Delhi, for their botanical identity. Voucher specimens were stored in the departmental laboratory.

Preparation of test drug

The formulation was prepared following the classical method in the departmental laboratory[5],[6] [Table 1]. The prepared Vati (pill) was stored in airtight glass containers, placed at specified storing conditions to evaluate shelf life.

Sample quantity and packing

The Vati was packed in five airtight glass containers [Figure 1] containing 100 Vatis (75 g) in each and stored for the accelerated stability study.
Figure 1: Containers of Sarpagandha ghana vati (each containing 100 Vatis)

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Study period

The study was conducted in between August 2019 and February 2020.

Storage conditions in the stability chamber

The accelerated stability was conducted following the ICH guidelines.[4] The temperature was maintained at 40 ± 2°C, whereas the relative humidity was 75 ± 5%.

Frequency of withdrawal of the sample

The sample was withdrawn from the stability chamber and evaluated for relevant parameters initially and at the intervals of 1, 3, and 6 months.

Physiochemical analysis

The formulation was studied at the specified intervals for changes in organoleptic parameters including color, odor, taste, and physicochemical parameters including uniformity of weight,[7] disintegration time,[8] friability (% w/w),[7] hardness (kg),[9] assay of total alkaloids,[10] and tests for microbial contamination.[11] The changes observed at these intervals were considered in further analysis.


  Observations and Results Top


The product was analyzed for basic analytical parameters initially and after storing under the accelerated conditions for 1, 3, and 6 months. The product retained its organoleptic features [Table 2] even after storing for 6 months in the stability chamber. The observations of various analytical parameters at the specified intervals of 1, 3, and 6 months [Table 3] were analyzed to calculate the intercept and slope [Table 4] and [Graph 1], [Graph 2], [Graph 3], [Graph 4], [Graph 5], [Graph 6], and the number of months when 10% degradation of the formulation occurred was calculated using the formula: Months when 10% degradation occurs = (0 month assay value [0 month assay value × 10/100]) intercept/slope. The mean months for 10% degradation was found to be 4.98 that was multiplied by the factor (3.33)[12] [Table 5]. Thus, the shelf life of Sarpagandha ghana vati was found as 1 year and 4 months [Table 6].
Table 2: Organoleptic characters of Sarpagandha ghana vati

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Table 3: Analytical profile of Sarpagandha ghana vati at different intervals

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Table 4: Intercept and slope of Sarpagandha ghana vati

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{Table 4}
Table 5: Approximate period for 10% degradation in Sarpagandha ghana vati

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Table 6: Extrapolation of shelf life in Sarpagandha ghana vati

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  Discussion Top


Stability is a vital quality control parameter determines the time when a product is considered to be safe and therapeutically effective under a relevant storage condition. Factors affecting the shelf life include humidity, temperature, light, microbial contamination, storage conditions, and packaging system. After the Gazette of Govternment of India, it became mandatory to mention the shelf life on the label of all marketing formulations that are equally applicable to Ayurvedic medicines also.[13] Possibly considering this, few works with special reference to Rasayana churna,[14] Trivrit avaleha,[15] Kamsaharitaki avaleha,[16] Shirishashwagandhadi avaleha,[17] Hridya yoga churna,[18] Shirishavaleha,[19] Laghu sutashekhara rasa,[12] Indukanta ghritam,[20] etc., were carried out. Although Sarpagandha ghana vati is an important formulation being used frequently across the country, its stability profile is not available. Thus, an effort has been made to evaluate the shelf life of Sarpagandha ghana vati by following accelerated stability protocol.

Under the accelerated stability conditions, the organoleptic characters of the formulation were unchanged, whereas the observations at the specified intervals in uniformity of weight, disintegration time, and hardness were negligible inferring that the product is stable during the period of analysis. Total Plate Count (TPC) indicates the probable level of microorganisms in a product. Large numbers of TPC may be an indication of poor sanitation or storing conditions or problems with process control or even ingredients. TPC was within the prescribed limits of API initially[11] that got reduced considerably by 6th month. This reduction also infers that the product is manufactured by the following standard protocols and stored at appropriate conditions.

After analyzing the observations, the shelf life of Sarpagandha ghana vati was found to be 1 year and 4 months. The shelf life of Vati has been mentioned as 1 year in the classics.[1] In the Gazette of India, the shelf life of Ghana vati has been mentioned as 3 years.[21] This stability can differ from one formulation to another, depending on the nature of the formulation, characteristics of individual components, etc. The commentator of Sharangadhara samhita also opined the same.[22] The current observations of Sarpagandha ghana vati are specific to the formulation.


  Conclusion Top


The preliminary analysis through accelerated stability study reveals that the shelf life of Sarpagandha ghana vati is 1 year and 4 months when stored under accelerated conditions in glass jars. This time period is specific to the formulation and is lower than the time factor specified in the Gazette of India. This evaluation is preliminary in nature, and further experiments may be conducted considering all the remaining relevant parameters.

Acknowledgment

The authors would like to acknowledge the support extended by the Director, AIIA, New Delhi, and technical support extended by Vasu Pharmaceuticals, Baroda, in conducting the shelf-life analysis of the product.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Vidyasagar PS, editor. Sharangadhara Samhita. Purva Khanda. 1/51-3. Varanasi: Chaukhamba Surbharti Prakashan; 2013. p. 13.  Back to cited text no. 1
    
2.
Tripathi H, editor. Vangasena Samhita of Vangasena. Jwaradhikara 2/677. Varanasi: Chowkhamba Sanskrita Series Office; 2009. p. 71.  Back to cited text no. 2
    
3.
Anonymous. Shastri L, editor. Yogratnakara. Jwara Chikitsa. Varanasi: Chaukhamba Sanskrit Sansthan; 2005. p. 203.  Back to cited text no. 3
    
4.
Food and Drug Administration, HHS. International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice. Fed Regist 2001;66:56332-3.  Back to cited text no. 4
    
5.
Acharya YT, Siddhayoga Sangraha, Shooladhikara. Allahabad: Baidyanath, Ayurveda Bhavan Ltd; 2018. p. 101.  Back to cited text no. 5
    
6.
Anonymous. In: Government of India, Ministry of Health and Family Welfare. Department of Indian Systems of Medicine and Homoeopathy. The Ayurvedic Formulary of India. Part II., 1st ed. New Delhi: The Controller of Publications Civil Lines; 2007. p. 181.  Back to cited text no. 6
    
7.
Unites States Pharmacopoeia Convention. United States Pharmacopoeia 38-National Formulary 33. USA: Stationery Office; 2010.  Back to cited text no. 7
    
8.
Indian Pharmacopoeia Commission. Indian Pharmacopoeia. 7th ed. Ghaziabad: Indian Pharmacopoeia Commission; 2014.  Back to cited text no. 8
    
9.
Mathur N, Kumar R, Tiwari K, Singh S, Fatima N. Evaluation of quality control parameters on various brands of paracetamol tablet formulation. World J Pharm Pharm Sci 2015;4:979.  Back to cited text no. 9
    
10.
Anonymous. Tests and determinations (Appendix 2). In: Government of India, Ministry of Health and Family Welfare. Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy, editor. Ayurvedic Pharmacopoeia of India. Part I., 1st ed., Vol. 2. Appendix 2.2.11. New Delhi: The Controller of Publications Civil Lines; 1999. p. 194.  Back to cited text no. 10
    
11.
Anonymous. Tests and determinations (Appendix 2). In: Government of India, Ministry of Health and Family Welfare. Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy, editor. Ayurvedic Pharmacopoeia of India. Part II., 1st ed., Vol. 1. Appendix 2.4. New Delhi: The Controller of Publications Civil Lines; 2007. p. 163.  Back to cited text no. 11
    
12.
Shweta M, Shivshankar R, Galib,Vaghela DB. Shelf life evaluation of laghu sutashekhara rasa – A preliminary assessment. J Ayurveda Integr Med 2020;11:213-6.  Back to cited text no. 12
    
13.
Galib R, Gulati P, Yadav P, Prajapati PK. Physicochemical profile and shelf life estimation of Nishamalaki churna. J Drug Res Ayurvedic Sci 2018;3:133-40.  Back to cited text no. 13
    
14.
Verma P, Galib, Patgiri B, Prajapati PK. Shelf-life evaluation of rasayana churna: A preliminary study. Ayu 2014;35:184-6.  Back to cited text no. 14
[PUBMED]  [Full text]  
15.
Rajput S, Mata S, Ruknuddin G, Dei L. Shelf life evaluation of trivrit avaleha – A preliminary assessment. J Ayu Med Sci 2017;2:230-3.  Back to cited text no. 15
    
16.
Khemuka N, Galib R, Patgiri BJ, Prajapati PK. Shelf-life evaluation of Kamsaharītakī avaleha and its granules: A preliminary study. Anc Sci Life 2015;35:96-100.  Back to cited text no. 16
    
17.
Dave P, Ruknuddin G, Jadav H. Shelf life assessment of shirisha ashwagandhadi avaleha – A preliminary assessment. J Med Pharm Allied Sci 2016:302-13.  Back to cited text no. 17
    
18.
Unnikrishnan V, Nishteswar K, Patel BR. Shelf life evaluation and comparative HPTLC profile of hridya yoga churna. Pharmacogn J 2016;8:234-8.  Back to cited text no. 18
    
19.
Kaur H, Ruknuddin G, Prajapati PK. Shelf life evaluation of shirishavaleha: A preliminary study. BLDE Univ J Health Sci 2016;1:120-4.  Back to cited text no. 19
  [Full text]  
20.
Aggarwal P, Ruknuddin G, Prajapati PK. Shelf-life evaluation of indukanta ghritam: A preliminary study. J Indian Sys Medicine 2020;8:210-6.  Back to cited text no. 20
  [Full text]  
21.
Anonymous. The Gazette of India. Extraordinary Part (II), Section (3), Sub- Section (1). New Delhi: Anonymous; 2016. p. 561.  Back to cited text no. 21
    
22.
Pandit Parashuram Shastri, editor. Adhamalla and Kashirama Commentory on Sharangdhara Samhita, Purva Khanda of Sharangdhara. Ch. 1. New Delhi: Chaukhamba Surbharati Prakashan; 2013. p. 13-4.  Back to cited text no. 22
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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