Abstract
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.
Highlights
ACF chemically is [(2,6-dichlorophenyl)amino] phenylacetoxyacetic acid [1]. It is used as an effective non-steroidal anti-inflammatory drug (NSAID)
The 2 μL solution of standard Rabeprazole Sodium (RZL) and ACF were spotted on Thin layer chromatography (TLC) plates and plate was developed in different solvent systems
The TLC plate was developed with first two bands of RZL, mixture of RZL and ACF which indicates the clear separation of two drugs, followed by two bands of ACF Fig. 1
Summary
ACF chemically is [(2,6-dichlorophenyl)amino] phenylacetoxyacetic acid [1]. It is used as an effective non-steroidal anti-inflammatory drug (NSAID). It is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the gastric H+, K+-ATPase enzyme system at the secretory surface of the gastric parietal cell and used in the treatment of gastroesophageal reflux disease (GERD) and duodenal ulcers [4] The combination of these two drugs has therapeutic indication in variety of painful conditions like rheumatoid arthritis, osteoarthritis and ankylosing spondylatis [5]. Developed and validated analytical method may be useful for various purposes including the forced degradation of drugs. It shows the chemical behaviour of the molecule which in turn helps in the development of formulation and package [12]. Analytical method is considered suitable for forced degradation, if it is able to separate the band of drug molecule from that of degraded products with acceptable recovery profile of drug for further study. The available ICH guidelines on stability testing of new drug substances and drug products and evaluation of stability data are helpful in this context [13,14]
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