RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical Formulations

Objective To develop an easy efficient and rapid analytical technique for the development and validation of Labetalol in dosage forms. Methods The drug was eluted isocratically using a Shimpack C18 4.6 x 250 mm 5mum column in mode using Acetonitrile and Phosphate buffer pH 6.5 6040 vv at 1 mLmin with 306 nm as detection wavelength at 3.3 min.Results This method showed a linear response for concentrations 10 to 50 mugmL with 0.9998 as correlation coefficient. The current method was validated in terms of system suitability specificity linearity precision accuracy LOD Limit of detec tion LOQ Limit of quantification and robustness. The recovery of Labetalol HCl was found to be 101.26. The percentage assay of Labetalol HCl present in the marketed formulation Labebet-100 mg was found to be 102.34. Conclusion Thus this proposed method can be successfully executed for the routine analytical work of Labeta lol HCl in bulk and tablet dosage forms in accordance with ICH Q2 R1 guidelines.