STABILITY INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF ACEBROPHYLLINE AND DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMAbstract
Objective: To develop a simple, selective, and precise stability-indicating high-performance liquid chromatography method for the simultaneous estimation of acebrophylline and doxofylline in bulk and tablet dosage form. Methods: The chromatographic separation achieved on HiQSil C18 Column (250 × 4.6 mm, 5µm) utilizing a mobile phase Acetonitrile: 10 mM n-hexane sulfonic acid buffer (80: 20, v/v) at a flow rate of 1.0 ml/min with injection volume 20 μl. UV detection was performed at 250 nm. The method was validated as per ICH guidelines. Results: The retention time for acebrophylline and doxofylline was found to be 2.77 min and 9.56 min, respectively. The linear regression analysis data for the calibration plots showed a good linear relationship in the concentration range of 1-10 μg/ml for acebrophylline and 4-24 µg/ml for doxofylline. The percentage recoveries of acebrophylline and doxofylline in the marketed dosage form were found to be 99.91 and 94.24, respectively. The correlation coefficients for acebrophylline and doxofylline were 0.997 and 0.998, respectively. The percentage degradation at different stress conditions like acid, alkaline, Neutral, oxidative, Dry heat, and photolytic for acebrophylline were found to be 14.84, 10.17, 9.5,11.34, 0.00 and 5.45 respectively and for doxofylline, found to be 8.19, 11.57, 12.74, 8.38, 9.57 and 11.02 respectively. Conclusion: The developed method was successfully validated as per ICH guidelines. This method is simple, selective, linear, precise, accurate, and sensitive and can be applied for routine estimation of tablet dosage forms containing both drugs.
Ram S. Sakhare *, Sanjay S. Pekamwar and Narendra Gangadharrao Patre
Department of Quality Assurance, Channabasweshwar Pharmacy College (Degree), Latur, Maharashtra, India.
28 May 2021
02 July 2021
08 July 2021
01 March 2022