DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF LINAGLIPTIN IN TABLET DOSAGE FORM
Vivek D. Zade*, Akshay N. Deo, Khushal B. Rathod and Aniket N. Timble
ABSTRACT
Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Linagliptin in tablet dosage form. Methods: The drug is soluble in Analytical Grade 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 Analytical Grade 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 Linagliptin in tablet dosage form and also validated as per ICH guidelines. Results: The drug is freely soluble in Methanol, Sparingly soluble in Ethanol and very slightly soluble in Water and Isopropanol. So, the analytical grade Methanol is used as a diluent in method. The melting point of Linagliptin was found to be 192-193˚C (uncorrected). It showed absorption maxima 295 nm in analytical grade Methanol. On the basis of absorption spectrum the working concentration was set on 15 μg/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, 99 and 98.6% for three levels respectively. The % RSD for precision and ruggedness was found to be 0.82% and 0.52% respectively. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Linagliptin in tablet dosage form. The method could be considered for the determination of Linagliptin in quality control laboratories.
Keywords: Linagliptin, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.
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