Development and Validation of UV Spectroscopic Method for Estimation of Acebrophylline In Tablet Dosage Form
Aslam Patel1*, Rajshree Patil1, Swapnil Patil2, Kalpesh V. Sonar1
1.Department of Pharmaceutical Chemistry, Arunamai college of Pharmacy, North Maharashtra University, Mamurabad, Jalgaon (MH), INDIA 425001.
2.Department of Pharmaceutics, Vidya Bharati College Of Pharmacy, Amravati University, Amravati (MH) INDIA 444602.
To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Acebrophylline in tablet dosage form. The drug is freely soluble in analytical grade Ethanol. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade Ethanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of acebrophylline in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade Ethanol, slightly soluble in methanol and water. So, the analytical grade Ethanol is used as a diluent in method. The melting point of acebrophylline was found to be 213-214ËšC (uncorrected). It showed absorption maxima 251 nm in analytical grade Ethanol. On the basis of absorption spectrum the working concentration was set on 10µg/ml (PPM). The linearity was observed between 2-18 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.95%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Acebrophylline in tablet dosage form. The method could be considered for the determination of Acebrophylline in quality control laboratories.
Keywords: Acebrophylline, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.