Analytical Method Development and Validation for the Simultaneous Estimation of Desvenlafaxine Succinate and Clonazepam in Bulk and Tablet Dosage Form by RP –HPLC Method

A simple, precise, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Desvenlafaxine succinate and Clonazepam in bulk drug and pharmaceutical dosage forms. Chromatographic separation was achieved on a C18 column using a mobile phase consisting of buffer, methanol and acetonitrile in the ratio of 30:20:50, at a flow rate of 1.0 mL/min. Detection was carried out at a wavelength of 222 nm and the retention times of Desvenlafaxine succinate and Clonazepam was found to be 2.510 min and 4.397 min respectively. The method was validated according to ICH Q2(R1) guidelines for parameters such as linearity, accuracy, precision, specificity, robustness, and system suitability. Linearity was observed in the concentration range of 60-140 µg/mL for Desvenlafaxine succinate and 0.6-1.4 µg/mL for Clonazepam, with a correlation coefficient (R²) of 0.999 for both the drugs. The percentage recovery ranged between 98–102%, indicating the accuracy of the method. The precision studies showed %RSD values less than 2%, confirming the reproducibility. The method was found to be specific for Desvenlafaxine succinate and Clonazepam with no interference from formulation excipients. This validated method can be successfully applied for routine quality control analysis of Desvenlafaxine succinate and Clonazepam in bulk and pharmaceutical formulations.