Development and Validation of HPTLC Method for Determination of Edoxaban in Bulk and Tablet
*Corresponding Author E-mail: firstname.lastname@example.org
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.
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.
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%
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.
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.
Edoxaban, Toluene, Methanol, Triethylamine, HPTLC.