DEVELOPMENT AND VALIDATION OF SIMPLE UV-SPECTROPHOTOMETRIC METHOD FOR QUANTITATION OF DIAZEPAM IN API AND SOLID DOSAGE FORMULATION
Dr. Shabana Naz Shah*
ABSTRACT
A very simple, accurate, precise, versatile and least economic UV spectrophotometric method for the quantitation of Diazepam in Active Pharmaceutical Ingredient and tablet dosage formulation have been developed using absorbance ratio method and validated as per ICH guidelines. In present study the absorbance values at 285nm were used for the estimation of diazepam. The results of analyses have been validated statistically for linearity, accuracy, precision, LOD and LOQ. The method was found to be linear in concentration range of 2-24 ?g mL-1 with correlation coefficient 0.9997 for diazepam. The results of validation parameters also indicated that proposed method was found to be accurate, precise, reproducible, sensitive and suitable for routine quality control analysis for estimation of diazepam in API and solid dosage formulation.
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