
The validated spectrophotometric method for the estimation of labetalol hydrochloride (LBH) using a dye-drug reaction demonstrates a robust and reliable analytical technique for routine pharmaceutical analysis. The method involves the formation of a colored complex between LBH and methyl orange, which is measured spectrophotometrically. LBH showed varying solubility in different solvents: sparingly soluble in water, freely soluble in 0.1 N HCl, slightly soluble in 0.1 N NaOH, and soluble in both methanol and ethanol. Among various dyes tested, methyl orange was selected due to its positive reaction with LBH, forming a stable colored complex. The maximum wavelength (λmax) for the methyl orange-LBH complex was determined to be 433 nm. The method exhibited excellent linearity over a concentration range of 2-10 μg/ml with a correlation coefficient (r²) of 0.99984, indicating a strong linear relationship between absorbance and concentration. The method showed high repeatability with low %RSD values across different concentrations. Analyst-to-analyst variation and day-to-day variation studies confirmed the method’s precision and robustness, with %RSD values within acceptable limits. Recovery studies at 80%, 100%, and 120% levels demonstrated the method's accuracy, with mean recovery percentages close to 100% and low %RSD values. The LOD and LOQ were determined to be 0.25 mg/ml and 1.75 mg/ml, respectively, indicating the method's sensitivity. This validated spectrophotometric method for estimating labetalol hydrochloride using the methyl orange dye-drug reaction is precise, accurate, and reliable. The method’s high sensitivity, excellent linearity, and robust recovery studies make it suitable for routine quality control and pharmaceutical analysis of LBH. The low variability in repeatability and inter-analyst tests further confirm the method’s applicability in ensuring consistent and reproducible results in various laboratory settings. Overall, this method provides a valuable analytical tool for the effective quantification of LBH in different formulations and samples. Keywords: Labetalol hydrochloride, Spectrophotometric method, Dye-drug reaction, Methyl orange, Analytical technique, Pharmaceutical analysis
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