Stability indicating HPTLC method development and validation for acebrophylline in bulk and its tablet dosage form Kashid Arun Maruti1,*, Khilare Amey Chandrakant2, Sable Shivanjali Balasaheb2 1Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India - 41 2Department of Pharmaceutical Quality Assurance, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India - 41 *Corresponding Author E-mail: arunkashid2006@gmail.com
Online Published on 23 January, 2024. Abstract A simple, precise, accurate stability-indicating method was developed and validated for Acebrophylline in bulk and tablet dosage form. The chromatographic separation was achieved by using Methanol: Acetonitrile: Acetone: Formic acid (4:4:2:0.1 v/v/v/v) as mobile phase and UV detection at 272nm. The retention factor for Acebrophylline was found to be 0.74±0.10. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation, and robustness as per ICH guidelines. Results were found to be linear in the concentration range of 400-2400ng band-1 with a correlation coefficient of 0.9921. The % assay was found to be 102.4±5. The drug was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis, and thermal degradation. The developed method can be used for the quantification of drug in the dosage form, bulk drug as well as for routine analysis in quality control laboratories. Top Keywords Acebrophylline, Method development, HPTLC, Validation, ICH guidelines. Top |