Development of Validated Stability Indicating HPTLC Method for Assay of Ozagrel and its Pharmaceutical Formulations

Authors(2) :-Vishal N Kushare, Sachin S Kushare

The present paper describes stability indicating high-performance thin-layer chromatography (HPTLC) assay method for Ozagrel in bulk drugs. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene: methanol: triethylamine (6.5: 4.0: 0.1 v/v/v). The system was found to give compact spot for Ozagrel (Rf value of 0.40 ± 0.010). Densitometric analysis of Ozagrel was carried out in the absorbance mode at 280 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.999 with respect to peak area in the concentration range 30 - 120 ng/spot. The developed HPTLC method was validated with respect to accuracy, precision, recovery and robustness. Also to determine related substance and assay determination of Ozagrel that can be used to evaluate the quality of regular production samples. The developed method can also be conveniently used for the assay determination of Ozagrel in pharmaceutical formulations. The limits of detection and quantitation were 4.069 and 12.332 ng/spot, respectively by height. Ozagrel was subjected to acid and alkali hydrolysis, oxidation, photochemical and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of Ozagrel in bulk drug and tablet formulation.

Authors and Affiliations

Vishal N Kushare
N.D.M.V.P Institute of Pharmaceutical Science, Adgaon Nashik, Maharashtra, India
Sachin S Kushare
Department of chemistry, Research Center, HPT arts RYK Science College, Nashik, Maharashtra, India

Ozagrel, validation, HPTLC

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Publication Details

Published in : Volume 4 | Issue 11 | November-December 2018
Date of Publication : 2018-11-30
License:  This work is licensed under a Creative Commons Attribution 4.0 International License.
Page(s) : 36-48
Manuscript Number : IJSRSET11841111
Publisher : Technoscience Academy

Print ISSN : 2395-1990, Online ISSN : 2394-4099

Cite This Article :

Vishal N Kushare, Sachin S Kushare, " Development of Validated Stability Indicating HPTLC Method for Assay of Ozagrel and its Pharmaceutical Formulations, International Journal of Scientific Research in Science, Engineering and Technology(IJSRSET), Print ISSN : 2395-1990, Online ISSN : 2394-4099, Volume 4, Issue 11, pp.36-48, November-December-2018. Available at doi : https://doi.org/10.32628/IJSRSET11841111
Journal URL : http://ijsrset.com/IJSRSET11841111

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