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TITLE:

METHOD DEVELOPMENT AND VALIDATION OF PROPRANOLOL HCL BY UV SPECTROSCOPIC METHOD IN A BULK AND PHARMACEUTICAL DOSAGE FORM

AUTHORS:

Mrs. Kansa Noori*, G . Narendar, CH. Anjali, G. Srilatha, B. Vani, Santosh Illendula,K.N.V. Rao, K. Rajeswar Dutt.

ABSTRACT:

A new simple, accurate, rapid, precise, reproducible and cost-effective spectrophotometric method for the quantitative estimation of Propranolol Hcl in bulk and pharmaceutical dosage form. The developed UV spectrophotometric method for the quantitative estimation of Propranolol Hcl is based on measurement of absorption at maximum wavelength 228 nm using Acetonitrile with buffer as a solvent. The stock solution of Propranolol Hcl was prepared, and subsequent suitable dilution was prepared in acetonitrile: buffer to obtained standard curve. The standard solution of Propranolol Hcl shows absorption maxima at 228 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25 μg/ml with regression 0.999 at 228 nm. The overall % recovery was found to be 99.03% which reflects that the method was free from the interference of the impurities and other excipients used in the bulk and marketed dosage form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.173 and 0.17 respectively which is <2% hence proved that method is precise. The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of Propranolol Hcl in bulk and tablet dosage form. Keywords: Propranolol Hcl, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Acetonitrile , Accuracy, Precision.

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