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Asian Journal of Pharmaceutical Analysis
Year : 2019, Volume : 9, Issue : 3
First page : ( 161) Last page : ( 166)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2019.00029.2

Development and Validation of HPTLC Method for Determination of Edoxaban in Bulk and Tablet

Ms. Dhiware Tarkeshwari K.1,*, Mr. Patil Paresh A.2, Mr. Salaraya Mahesh G.3

1C. K. Pithawalla Institute of Pharmaceutical Science and Research, Surat, (Gujarat) 395007 [India]

2Ahinsa Institute of Pharmacy, Dondaicha, Shindkheda, Dhule. (MS) 425408 [India]

3C. K. Pithawalla Institute of Pharmaceutical Science and Research, Surat, (Gujarat) 395007 [India]

*Corresponding Author E-mail: tarkeshwaridhiware16@gmail.com

Online published on 31 December, 2019.

Abstract

Objective

To develop as simple and sensitive, high-performance thin layer chromatography (HPTLC) method for the quantitative estimation of Edoxaban in bulk and tablet. Validation of developed methods for linearity, accuracy, precision, ruggedness as per ICH guidelines.

Method

Sample of edoxaban was applied on precoated silica gel 60F254 glass plate (20 × 10 cm with 200 μm thickness HPTLC, Merck) TLC plate under pure nitrogen stream by Camage Linomat automic sample applicator. Separation was carried out by using the mobile phase of toluene: methanol: triethylamine and ratio (7.5: 1: 0.2, v/v/v). Developed TLC plates were scanned by camag TLC scanner and detection was carried out at 230 nm.

Result

Rf value of Edoxaban was found to be 0.6. linearity was found from 400–2400 ng/band. The mean percentage recovery was found to be 98.4%

Materials

The drug was used without further purification. As the tablet formulation was not available in Indian market; tablet containing 15, 30, 60mg Edoxaban were prepared in-house using direct compression technique. Prepared tablets were used as pharmaceutical formulation for further analysis.

Conclusion

The present study represents first HPTLC method that deals with the estimation of Edoxaban. Validation results indicated that the developed method is simple, rapid, accurate, specific, sensitive and precise. The developed method was validated as per ICH Q2 (R1) guideline by studying various validation parameters like accuracy, precision, specificity, assay, LOD and LOQ. It can be concluded that the method can be used inroutine analysis of Edoxaban in tablet dosage form.

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Keywords

Edoxaban, Toluene, Methanol, Triethylamine, HPTLC.

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