Uv Spectrophotometric Method Development and Validation for the Quantitative Estimation of Indinavir Sulphate in Capsules

Objective: To develop a simple and cheap 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 4.0) for the estimation of assay of Indinavir sulphate whose λmax 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 1.44%. 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 14.42 μg/ml and 43.69 μg/ml respectively. Conclusion: A simple and a cheap 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.