Author(s): Arun Maruti Kashid, Amey Chandrakant Khilare, Shivanjali Balasaheb Sable

Email(s): arunkashid2006@gmail.com

DOI: 10.52711/2231-5675.2023.00042   

Address: Arun Maruti Kashid1*, Amey Chandrakant Khilare2, Shivanjali Balasaheb Sable2
1Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India - 41.
2 Department of Pharmaceutical Quality Assurance, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India – 41.
*Corresponding Author

Published In:   Volume - 13,      Issue - 4,     Year - 2023


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.


Cite this article:
Arun Maruti Kashid, Amey Chandrakant Khilare, Shivanjali Balasaheb Sable. Stability Indicating HPTLC Method Development and Validation for Acebrophylline in Bulk and its Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(4):255-0. doi: 10.52711/2231-5675.2023.00042

Cite(Electronic):
Arun Maruti Kashid, Amey Chandrakant Khilare, Shivanjali Balasaheb Sable. Stability Indicating HPTLC Method Development and Validation for Acebrophylline in Bulk and its Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(4):255-0. doi: 10.52711/2231-5675.2023.00042   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-4-6


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