Development and validation of reversed phase? high-performance liquid chromatography method for determination of paracetamol and lornoxicam in tablet dosage form


Author(s): Deepak Kumar Jain, Pratibha Patel, H. S. Chandel, Abhay Kushwaha, and Nilesh Jain

A simple, precise, reliable, rapid and reproducible reversed phase–high-performance liquid chromatography method was developed and validated for the simultaneous estimation of Paracetamol (PCM) and Lornoxicam (LOX) present in tablet dosage forms. Chromatographic separation achieved isocratically on Luna C18 column (5 μm, 150 × 4.60 mm) and methanol/ phosphate buffer (60:40, v/v, pH 7.0) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 260 nm. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the ICH guidelines. The retention times for PCM and LOX was found to be 2.06±0.013and 4.38±0.07 min, respectively. Linearity for PCM and LOX was in the range of 10-50 mg/ml and 8-40 mg/ml, respectively. The mean recoveries obtained for LOX and PCM were 100±0.16 and 99.50±0.43%, respectively, and relative standard deviation (RSD) was less than 2. The correlation coefficients for all components are close to 1. The RSDs for three replicate measurements in three concentrations of samples in tablets are always less than 2%. Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of PCM and LOX in tablets.