European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF GLIPIZIDE IN TABLET DOSAGE FORM

Karuna P. Joshi*, Harshada B. Kumawat, Mayuri S. Mahajan, Harshal D. Kamde, Dipak B. Kamble, Rahul D. Mali and Sagar R. Mahajan

ABSTRACT

Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Glipizide in tablet dosage form. Methods: The drug is freely soluble in 0.1N NaOH.[1] The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics.[2] It showed absorption maxima were determined in 0.1N NaOH. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity.[3, 4, 5, 6] The UV spectroscopic method was developed for estimation of Glipizide in tablet dosage form and also validated as per ICH guidelines.[7] Results: The drug is freely soluble in 0.1N NaOH, slightly soluble in methylene chloride and practically insoluble in water and ethanol. So, the 0.1N NaOH is used as a diluent in method. The melting point of Glipizide was found to be 208-209˚C (uncorrected). It showed absorption maxima 272 nm in 0.1N NaOH. On the basis of absorption spectrum the working concentration was set on 20 μg/ml (PPM). The linearity was observed between 10-30 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.7, 101 and 99.2% for three levels respectively. The % RSD for precision was found to be 0.62%. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Glipizide in tablet dosage form. The method could be considered for the determination of Glipizide in quality control laboratories.

Keywords: Glipizide, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.