Validated Stability Indicating HPTLC Method Development for Rivaroxaban in Tablets

Objectives

The present goal of this analytical study is to develop a simple, reliable, sensitive and robust method that can identify Rivaroxaban (RVB) by using high performance thin liquid chromatography. The current study included a degradation study by using different stress conditions in drug and tablets by using HPTLC.

Materials and Methods

The analysis was performed by using the HPTLC CAMAG system compromising Linomat 5 sample applicator at wavelength 284 nm. Mobile phase selected as toluene (3 mL): ethyl acetate (5.5 mL): methanol (1.5 mL): ammonia (0.1 mL) with ten-minute saturation time.

Results

The parameters like linearity and range, LOD and LOQ, accuracy, robustness, precision was studied for validation. RVB was subjected under the circumstance of forced degradation conditions like hydrolysis (base, acid, neutral), thermal, photolysis and oxidation. Using precoated silica plate as a stationary phase, the retention factor for RVB was 0.57±0.05 found. The reported HPTLC method shows a linear graph in the range of 200-1200 ng/band having regression coefficient is 0.9971. The linear regression equation was obtained as y=6.7609x+55.08. The prominent degradation shows at acidic, basic and oxidative conditions. In acidic condition drug was observed more degraded as compare to other conditions.

Conclusion

HPTLC method is useful to identify and separate the degradant using mass spectra. No degradation was observed at thermal and photolytic conditions.