WHO Guided Real Time Stability Testing on Shankhpushpi Syrup

Published: May 5, 2017

Authors

  • Astha JainDepartment of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147001, Punjab, India
  • Astha JainDepartment of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147001, Punjab, India
  • Jasmeen KaurDepartment of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147001, Punjab, India
  • Nancy, Yogita BansalDepartment of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147001, Punjab, India
  • Balraj SainiDepartment of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147001, Punjab, India
  • Gulshan BansalDepartment of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147001, Punjab, India
Keywords
Stability study, Convolvulus pluricaulis, Bacopamonnieri, Shankhpushpi syrup, Scopoletin, HPLC-UV, HPLC-PDA

Abstract

Shankhpushpiis widely used herb in numerous CNS active Ayurvedic formulations, which are consumed by population of all age groups. The present study is designed to evaluate the stability of commercially available shankhpushpi syrup as per WHO guidelines. The study was conducted under long term conditions for 12 months on three different batches of the product. An HPLC-UV method was developed and validated to determine the marker (scopoletin) content in the stability samples. Peak purity was determined using HPLC-PDA analysis. Each stability sample was investigated for any change in physical, chemical and biological parameters with respect to control sample. The product was found to be stable in terms of physical parameters whereas significant change was observed in total phenolic content and content of scopoletin. The antioxidant, acetylcholine esterase inhibitory and antianxiety activities of the stability samples decreased with respect to control sample. Moreover, there was significant variation in chemical and biological parameters among the batches. The findings suggested that the product was unstable and further studies are required to be conducted in order to determine the shelf life of the product.

References

  • Arslan, E., Yener, M.E. and Esin, A. (2005)’Rheological characterization of tahin/pekmez (sesame paste/concentrated grape juice) blends’.Journal of Food Engineering, Vol 69, 2, pp. 167-172. https://doi.org/10.1016/j.jfoodeng.2004.08.010
  • Bourin, M. and Hascoet, M. (2003) ‘The mouse light/dark box test’.European Journal of Pharmacology, Vol 463, 1-3, pp. 55-65. https://doi.org/10.1016/s0014-2999(03)01274-3
  • Brown, R.E., Corey, S.C. and Moore, A.K. (1999) ‘Differences in Measures of Exploration and Fear in MHC-Congenic C57BL/6J and B6-H-2K Mice’.Behavior genetics, Vol 29, 4, pp. 263-271. https://doi.org/10.1023/A:1021694307672
  • Committee for Proprietary Medicinal Products (2003) Guideline on stability testing: Stability testing of existing active substances and related finished products CPMP/QWP/122/02 Rev1 corr., European Medicines Agency, London, UK.
  • Committee for Proprietary Medicinal Products (2003)Stability testing of New Drug Substances and Products CPMP/ICH/2736/99, European Medicines Agency, London, UK.
  • Committee on Herbal Medicinal Products (2008)Markers used for Quantitative and Qualitative analysis of Herbal Medicinal Products and Traditional Herbal Medicinal Products EMEA/ HMPC/253629/07, European Medicines Agency, London, UK.
  • Committee on Herbal Medicinal Products (2008)Quality of Combination Herbal Medicinal Products/Traditional Herbal Medicinal Products EMEA/HPMC/CHMP/CVMP/214869, European Medicines Agency, London, UK.
  • Committee on Herbal Medicinal Products (2010)Reflection paper on stability testing of Herbal Medicinal Products and Traditional Herbal Medicinal Products EMEA/HMPC/3626/09, European Medicines Agency, London, UK.
  • Ellman, G.L., Courtney, K.D., Andres, V. and Featherstone, R.M. (1961)’A new and rapid colorimetric determination of acetylcholinesterase activity’.Biochemical Pharmacology, Vol 7, 2, pp. 88-95. https://doi.org/10.1016/0006-2952(61)90145-9
  • Fu, L., Xu, B.T., Gan, R.Y., Zhang, Y., Xu, X.R., et al. (2011)’Total phenolic contents and antioxidant capacities of herbal and tea infusions’.International Journal of Molecular Sciences, Vol 12, 4, pp. 2112-2124. https://doi.org/10.3390/ijms12042112
  • International Conference on Harmonization (2003) Stability testing of New Drug Substances and Products ICH Q1A(R2), International Conference on Harmonization, Geneva, Switzerland.
  • Kulkarni, S.K. (1999),’Handbook of Experimental Pharmacology’ (3rd Ed.), Delhi.Vallabh Prakashan.
  • Kumari, S., Shukla, G. and Rao A.S. (2011) ‘The Present Status of Medicinal Plants-Aspects and Prospects’.International Journal of Research in Pharmaceutical and Biomedical Sciences, Vol 2, 1, pp. 19-22.
  • Locatelli, M., Gindro, R., Travaglia, F., Coïsson, J.D., Rinaldi, M., et al. (2009)’Study of the DPPH scavenging activity: Development of a free software for the correct interpretation of data’. Food Chemistry, Vol 114, 3, pp. 889-897. https://doi.org/10.1016/j.foodchem.2008.10.035
  • Phrompittayarat, W., Wittaya-areekul, S., Jetiyanon, K., Putalun, W., Tanaka, H., et al. (2008)’Stability studies of saponins in Bacopamonnieri dried ethanolic extracts’. Planta Medica, Vol 74, 14, pp. 1756-1763. https://doi.org/10.1055/s-0028-1088311
  • Reagan-Shaw, S., Nihal, M. and Ahmad, N. (2008)’Dose translation from animal to human studies revisited’. The FASEB Journal, Vol 22, 3, pp. 659-661. https://doi.org/10.1096/fj.07-9574LSF
  • Shahare, M.D. and D’Mello, P.M. (2010)’Standardization of BacopaMonnieri and its Formulations with reference to Bacoside A, by High Performance Thin Layer Chromatography’. International Journal of Pharmacognosy and Phytochemical Research, Vol 2, 4, pp. 8-12.
  • Srivastava, P., Raut, H.N., Puntambekar, H.M., Upadhye, A.S. and Desai, A.C. (2010)’Stability studies of crude plant material of Bacopamonnieri and its effect on free radical scavenging activity’.Journal of Phytology, Vol 2, 8, pp. 103-109.
  • Srivastava, P., Raut, H.N., Puntambekar, H.M. and Desai, A.C. (2012)’Stability studies of crude plant material of Bacopamonnieri and quantitative determination of bacopasideI and bacoside A by HPLC’. PhytochemicalAnalysis, Vol 23, 5, pp. 502-507. https://doi.org/10.1002/pca.2347
  • World Health Organisation (2009)Stability testing of active pharmaceutical ingredients and finished pharmaceutical products WHO Technical Report Series, No. 953, World Health Organisation, Geneva.

How to Cite

Astha Jain, Astha Jain, Jasmeen Kaur, Nancy, Yogita Bansal, Balraj Saini, Gulshan Bansal. WHO Guided Real Time Stability Testing on Shankhpushpi Syrup. J. Pharm. Technol. Res. Manag.. 2017, 05, 1-19
WHO Guided Real Time Stability Testing on Shankhpushpi Syrup

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