• Ram S. Sakhare
• Preeti G. Wangarwar
• Mukesh H. Muratkar
• Sunil S. Hindole

A simple, precise, and accurate stability-indicating high-performance thin layer chromatographic method for analysis of Prucalopride succinate It has been demonstrated and proven that in the presence of its degradation products. Optimum separation among Prucalopride succinate and the results of its degradation was achieved by use of silica gel 60F254 as stationary phase with Toluene: Methanol: Glacial acetic acid (7:2.5:0.5 v/v/v) as a mobile phase. Densitometric quantification was performed at 240 nm. The retention factor was revealed to be 0.25 ± 0.10for parent drug. The drug was subjected to different stress conditions like acid, base hydrolysis, oxidation, thermal degradation and photolysis. In accordance with ICH Q2 (R1) guidelines, the approach was successfully validated. The method exhibited an adequate linearity (r =0.995), selectivity, precision and accuracy. Prucalopride succinate in bulk and pharmaceutical dose form can be routinely analysed using the developed method.

Prucalopride succinate, Stability indicating method, ICH, HPTLC, Validation.

"Development and Validation of a Stability Indicating HPTLC Method for the Determination of Prucalopride succinate in Bulk and Tablet dosage form", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 4, page no.315-327, April-2023, Available :http://www.jetir.org/papers/JETIRFW06041.pdf

"Development and Validation of a Stability Indicating HPTLC Method for the Determination of Prucalopride succinate in Bulk and Tablet dosage form", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 4, page no. pp315-327, April-2023, Available at : http://www.jetir.org/papers/JETIRFW06041.pdf