A RAPID AND COST EFFECTIVE UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF INDINAVIR SULPHATE IN CAPSULES

摘要

Objective: To develop a cheap and rapid UV spectrophotometric method for the quantitative estimation of Indinavir sulphate (400mg) in capsules and validate as per ICH guidelines. Methods: The optimized method uses a diluent 100% potassium dihydrogen ortho phosphate buffer (pH 3.0) for the estimation of assay of Indinavir sulphate whose lmax is 259 nm. Results: The developed method resulted in Indinavir sulphate exhibiting linearity in the range 20-80 μg/ml. The precision is exemplified by relative standard deviation of 1.49%. Percentage Mean recovery was found to be in the range of 98‐102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) were found to be 5 mg/ml, and 16.27 mg/ml respectively. Conclusion: A cheap and rapid UV spectrophotometric method was developed and validated for the quantitative estimation of Indinavir sulphate in capsules as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries. Keywords: UV, Indinavir sulphate, Method development, Validation.