STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR ESTIMATION OF ADAPALENE IN TABLET FORMULATION

Abstract

Stability-indicating high performance liquid chromatographic (HPLC) method for estimation of Adapalene was developed and validated. Adapalene was separated and quantitated on Nucleosil C8 column (250 mm length, 4.6 mm internal diameter, 5 µm particle size) using a blend of methanol-ammonium acetate buffer pH 4.0 (80:20 v/v) as a mobile phase and at a flow rate of 1.3 mL/min. Quantification was achieved with ultraviolet (UV) detector at 270 nm over the concentration range 10–60 µg/mL. The applied HPLC method allowed separation and quantification of Adapalene with good linearity (r² = 0.999) in the studied concentration range. Limit of detection and limit of quantification were found to be 1.43 µg/mL and 4.34 µg/mL, respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. Adapalene stock solution was subjected to different stress conditions. The degraded product peaks were well-resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed HPLC method. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of Adapalene. The method was successfully applied to the estimation of Adapalene in tablet dosage forms.

Keywords:

• adapalene
• HPLC
• method development
• method validation
• stability indicating method
• tablet formulations

ACKNOWLEDGMENT

The authors are grateful to the Glenmark Pharmaceutical Ltd. (Mumbai, India) for providing gratis sample of APL.

Notes

^a LOD = Limit of detection.

^b LOQ = Limit of quantification.

^c RSD = Relative standard deviation.

^a SD˭Standard deviation.

^b n = Number of determination.