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Abstract

DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROSCOPIC METHOD FOR ESTIMATION OF CARBAMAZEPINE IN BULK AND TABLET DOSAGE FORM

Om Kharde*, Shubham Doifode Tanmay Dongaonkar and Prafulla Tathe

Abstract

A novel, simple, accurate, rapid, precise, reproducible and cost effective spectrophotometric method for the quantitative estimation of carbamazepine in a pharmaceutical formulation and validated according to the ICHQ2 (R1) guideline. Spiked carbamazepine solution was scanned over UV-visible range for its wavelength of maximum absorbance. Various calibration standards of carbamazepine were prepared and absorbance was recorded at wavelength of maximum absorbance. Calibration curve of concentration vs. absorbance was plotted and linearity and range was calculated. Various analytical method validation parameters viz. accuracy, precision, LOD, LOQ, and ruggedness were calculated using QC standards. The maximum wavelength of carbamazepine was found to be 246 nm. The drug obeyed beer lambert’s law in the concentration range of 2-12 μg/ml with regression 0.9992 at 284 nm. The overall % recovery was found to be 99.06 to 99.60 % which reflects that the method was free from the interference of the impurities and other excipients used in the formulation. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for interday and intra-day precision was found to be of 0.56 to 1.82 & 0.36 to 0.59 respectively which is

Keywords: UV- visible spectrometry, Carbamazepine, Validation.


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