DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF SWERTIAMARIN IN BULK AND DOSAGE FORM


H. Padh, S. Parmar, B. Patel

Abstract


Objective: In the present study a novel stability-indicating high-performance thin-layer chromatography (HPTLC) method for quantitative determination of Swertiamarin (SW) in bulk drug and formulation has been developed and validated as per ICH guideline Q2 (R1) for global acceptance of standardized herbal formulations.

Methods: HPTLC method is developed and validated using solvent ethyl acetate: ethanol: chloroform (3:2.5:4.5 v/v/v) (Rf of SW 0.65±0.04) in the absorbance mode at 243 nm. Various forced degradation conditions were used to check degradation of drug.

Results: The method showed a good linear relationship (r2 = 0.9990) in the concentration range 200-700 ng per spot. It was found to be linear, accurate, precise and specific.

Conclusion: It can be applied for quality control as well as for stability testing of different dosage forms containing swertiamarin. The developed method is validated as per ICH guideline Q2(R1) for global acceptance of standardized herbal formulations.


Keywords


Swertiamarin, Stability-indicating HPTLC method, ICH guidelines, Quality control

| PDF | HTML |

References


Sharma AK, Gaurav SS, Balkrishna A. A rapid and simple scheme for the standardization of polyherbal drugs. Int J Green Pharm 2009;3:134-40.

Chawla R. Evidence-based herbal drug standardization approach in coping with challenges of holistic management of diabetes: a dreadful lifestyle disorder of 21st century. J Diabetes Metab Disord 2013;12:35.

Vishwakarma SL. A sensitive HPTLC method for estimatin of swertiamarin in Enicostemma littorale blume. J Pharm Chem 2004;17:128-31.

Mani R, Kunchu K, Pallab KH. Role of herbal plants in the diabetes mellitus therapy: an overview. Int J Appl Pharm 2014;6:1-3.

Shapiro K, Gong WC. Natural products used for diabetes. J Am Pharm Assoc 2002;42:217-26.

Bhatt JA. Development and validation of analytical method for estimation of swertiamarin in a marketed preparation containing Enicostemma littrale. World J Pharm Pharm Sci 2016;5:1467-78.

Ahamad J, Amin S, Mir SR. Development and validation of HPLC-UV method for estimation of swertiamarin in Enicostemma littorale. J Pharm BioSci 2014;9:1467-78.

Alam P. A new HPTLC densitometric method for analysis of swertiamarin in E. Littorale and commercial formulations. Nat Pro Res 2011;25:17-25.

Lu CM, Lin LC, Tsai TH. Determination and pharmacokinetic study of gentiopicroside, geniposide, baicalin and swertiamarin in Chinese herbal formulae after oral administration in rats by LC-MS/MS. Molecules 2014;19:21560-78.

Li HL. Determination of the pharmacokinetic and tissue distributions of swertiamarin in rats by LCMS. Thieme E J 2012;6:138-44.




About this article

Title

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF SWERTIAMARIN IN BULK AND DOSAGE FORM

Keywords

Swertiamarin, Stability-indicating HPTLC method, ICH guidelines, Quality control

DOI

10.22159/ijap.2017v9i6.22214

Date

08-11-2017

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 9, Issue 6 (Oct-Nov), 2017 Page: 80-84

Online ISSN

0975-7058

Statistics

17 Views | 8 Downloads

Authors & Affiliations

H. Padh
Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar – 388120, India
India

S. Parmar
Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar – 388120, India

B. Patel
Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar – 388120, India
India


Refbacks

  • There are currently no refbacks.