Development of Validated Stability-indicating High Performance Thin Layer Chromatography Method for Estimation of Rabeprazole Sodium and Aceclofenac in Bulk Drug

Objective: To develop a validated stability-indicating high performance thin layer chromatography method for the estimation of Rabeprazole Sodium (RZL) and Aceclofenac (ACF) in bulk drugs.

Methods: A high performance thin layer chromatographic (HPTLC) method has been developed for the separation of RZL & ACF on plates precoated with aluminium back silica gel 60 F254. Different mobile phases were used on trial and error basis for separation of two drugs. The final mobile phase selected for analysis was toluene: ethyl acetate: methanol: acetic acid: ammonia in the ration of 6:4:1:0.2:0.1 (v/v). Both the drugs showed maximum absorbance at 279 nm which was selected as the detection wavelength throughout the experimental work. Developed method was validated as per ICH guidelines. Forced degradation of drugs was carried out under various stress conditions and HPTLC method was used for analysing the stability of drugs.

Results: HPTLC method was successfully developed for separation of RZL and ACF with clear separation of bands of the drugs. Method validation after assessment of various parameters indicated low % RSD within an acceptable limit of < 2.0 and the stability studies indicated the satisfactory separation of both the drugs from that of degraded products with considerable % recovery profile.

Conclusion: The developed method is rapid, reliable, precise, and reproducible and demonstrates the suitability of the method for stability determination of rabeprazole and aceclofenac.