Stability-Indicating RP-HPLC Method Development, Qbd Optimization and Validation for assessing Related Impurities in Labetalol Hydrochloride bulk and injectable form

The Current study aimed to develop and validate a reliable Reverse Phase High- Performance Liquid Chromatography (RP-HPLC) method for the quantification of Labetalol Hydrochloride and its related substances by using design of Experiments (DoE). The mobile phase A consists of Phosphate buffer (pH 3.7) (100 %) and the mobile phase B consist of Acetonitrile (100 %). The UV detector wavelength was 230 nm. The total run time was 60 minutes and flow rate was 0.8ml/min. Various parameters such as linearity, precision, accuracy, specificity, robustness, ruggedness, solution stability, Forced degradation, limit of detection, limit of quantification and system suitability were thoroughly evaluated according to USP guidelines. The method exhibited excellent linearity over the concentration range of 0.000258 to 0.003096 mg/ml with a correlation coefficient (r2) of 0.999, The Method precision ( % RSD) were found to be within acceptable limits. Accuracy studies revealed that the method was accurate with recovery values within the range of 99.6 % to 102.5 %. The method demonstrated high specificity, as indicated by the resolution of Labetalol Hydrochloride peak from potential impurities. Robustness and Ruggedness testing confirmed the method ability to produce consistent results under slight variations in chromatographic conditions. Furthermore, system suitability parameters such as resolution, tailing factor, and theoretical plates met the acceptance criteria, ensuring the method suitability for routine analysis. Overall, the developed RP-HPLC method proved to be accurate, precise, specific, and robust for the quantitative determination of Labetalol Hydrochloride in pharmaceutical formulations, thereby offering a valuable tool for quality control in pharmaceutical industries.