Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 4 Issue 1

HPTLC Method Development for the Simultaneous Estimation of Ketorolac Tromethamine and Tramadol Hydrochloride from a Formulation

Vrushali S Tambe1*, Bijal P Gujarathi1, Archana Karnik2, SN Dhole1

1Department of Quality Assurance, P. E. S’s, Modern College of Pharmacy (For Ladies), Maharashtra, India
2Indira College of Pharmacy, Pune, India

*Corresponding Author: Vrushali S Tambe, Department of Quality Assurance Technique, PES’s Modern College of Pharmacy (For Ladies), Maharashtra, India.

Received: December 16, 2019; Published: December 27, 2019

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Abstract

Objective: The study was aimed to develop simple, specific, accurate HPTLC method for simultaneous determination of the Ketorolac Tromethamine and Tramadol HCl in pharmaceutical dosage form.

Material and Method: A rapid, selective and simple high performance thin layer chromatographic method was developed and validated for their simultaneous estimation in a mixture. Well resolved peaks were observed for both the drugs on aluminium sheet with silica gel 60 F254 as the stationary phase. The solvent system consisted of ethyl acetate: methanol: 25% ammonia solution [8.5: 1.5: 0.5 v/v/v]. The λmax were observed at 282nm and 271nm for Ketorolac Tromethamine and Tramadol HCl respectively. Spectrodensitometric scanning-integration was performed at a wavelength of 282 nm.

Results: This system was found to give compact spots for both Ketorolac [Rf value of 0.08 ± 0.01] and Tramadol [Rf value of 0.52 ± 0.02]. The polynomial regression data for the calibration plots showed good linear relationship in the concentration range of 200-700 ng/band for ketorolac [r2 =0.999] and 500-1750 ng/band for Tramadol [r2 = 0.995]. The LOD and LOQ were found to be 0.3912 ng/band and 1.7930 ng/band for Ketorolac and 4.6370 ng/band and 7.7551 ng/band for Tramadol, respectively. The peak purity of both drugs was found to be always more than 0.995 proving the specificity of the method.

Conclusion: The method was validated for linearity, LOD, LOQ, specificity, accuracy and precision as per ICH guidelines. The proposed method has demonstrated to have a potential use in simultaneous analysis of Ketorolac tromethamine and Tramadol hydrochloride from a tablet formulation.

Keywords: Ketorolac Tromethamine; Tramadol Hydrochloride; HPTLC Method; Simultaneous Estimation

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References

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Citation

Citation: Vrushali S Tambe., et al. “HPTLC Method Development for the Simultaneous Estimation of Ketorolac Tromethamine and Tramadol Hydrochloride from a Formulation". Acta Scientific Pharmaceutical Sciences 4.1 (2020): 84-88.



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