METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF INDINAVIR IN CAPSULES BY RP-HPLC
Keywords:
Nil, Indinavir sulphate, Method development, ValidationAbstract
Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Indinavir Sulphate (400mg) in capsules.
Methods: The developed method uses a reverse phase C18 column, INERTSIL ODS 3V column (250X4.6 mm; 5μ), mobile phase consisting of Potassium dihydrogen orthophosphate buffer (adjusted using 30% v/v of ortho phosphoric acid pH 3.5):methanol: acetonitrile in the proportion of 20:40:40 v/v. The mobile phase was set at a flow rate of 1.2 ml/min and the volume injected was 20μl for every injection. The detection wavelength was set at 220 nm.
Results: The developed method resulted in Indinavir sulphate eluting at 3.75 min. Indinavir sulphate exhibited linearity in the range 60-140μg/ml. The precision is exemplified by relative standard deviation of 0.709%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitation (LOQ) was found to be 104ng/ml and 315ng/ml respectively.
Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of Indinavir sulphate in INDIVIR (400mg) capsules as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.
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References
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