ABSTRACT

The New HPLC method was developed to estimate and validate the Gatifloxacin and Prednisolone in bulk and marketed formulation. Method development was carried out by HPLC Shimadzu 2030C 3D Plus with stationary phase as Hypersil ODS Column(150X4mm) using Mobile phase of Methanol and 0.1% TEA in water was pumped into the system at a flow rate of 0.6ml/min with injection volume 20 ?L and Photo diode array detector at 266 nm. Validation was done according to ICH Q2 (R1) guidelines. Linearity for Gatifloxacin 10- 50 ?g/mL and prednisolone is 50-125 ?g/mL, the Retention time of Gat and Pred was found to be 1.960,6.812 Respectively. Average correlation coefficient for linearity was found to be R2=0.999. With % RSD values ?2.0, the recovery studies was found to be 100.12 for Gatifloxacin and 99.85 for Prednisolone. The developed method is accurate for simultaneous estimation of two drugs. The LOD for Gatifloxacin is 1?g/mL and 3?g/mL for Prednisolone. The LOQ of Gatifloxacin is 3 ?g/mL of gatifloxacin and 15 ?g/mL of Prednisolone. The run time is 10 min. All the parameters like theoretical plates, resolution, tailing factor and %RSD was within acceptance limits. The developed method was useful for routine analysis of Gatifloxacin and Prednisolone. Keywords: Gatifloxacin, Prednisolone, Gatiquin p, HPLC, Assay
Publication date: 01/05/2023

https://ijbpas.com/pdf/2023/May/MS_IJBPAS_2023_7144.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.5.7144