DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF DELAMANID IN TABLET DOSAGE FORM
Neha Kharat*, Saloni Maindan, Abheet Pargane and Dhiraj Pawar
ABSTRACT
Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Delamanid in tablet dosage form. Methods: The drug is soluble in Methanol. 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 Methanol. 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 Delamanid in tablet dosage form and also validated as per ICH guidelines. Results: The drug is freely soluble in Methanol, soluble in ethanol and insoluble in water. So, the Methanol is used as a diluent in method. The melting point of Delamanid was found to be 189-190˚C (uncorrected). It showed absorption maxima 320 nm in Methanol. On the basis of absorption spectrum the working concentration was set on 15μg/ml (PPM). The linearity was observed between 5-25 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.8, 98.0 and 98.3% for three levels respectively. The % RSD for precision and ruggedness was found to be 0.72% and 0.52% respectively. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Delamanid in tablet dosage
Keywords: Delamanid, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.
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