A NEW HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM
Objective: To develop a new simple, selective and precise high-performance thin layer chromatographic method for determination of Dapagliflozin (DAPA) in bulk and tablet dosage form
Methods: The present study describes development and validation of High performance thin layer chromatographic method for DAPA. The chromatographic separation was carried out on Merck precoated silica gel aluminium plate 60 F254 using Chloroform: Methanol (9:1v/v) as mobile phase. Quantitative determination of drug was carried out by densitometric scanning of plates at 223 nm using Camag TLC Scanner.
Results: The chromatographic condition shows compact band with the retention factor for dapaglifloxin as 0.21 ± 0.004. The method was validated as per ICH guidelines for linearity, accuracy, precision and robustness. Response was found to be linear in the concentration range of 400 ng/ band to 1200 ng/band with linear regression value of 0.9953 with respect to peak area and concentration value The LOD and LOQ was found to be 1.2083 ng/band and 3.6616ng/ band. The percentage assay was found to be 100±0.05.
Conclusion: This method under statistical analysis proved a selective, repeatable and accurate analysis of the drug. This method can be used for quantitative analysis of dapaglifloxin in the bulk drug and in tablet.
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