Author(s): PRADNYA A KARBHARI, SNEHA J JOSHI, SUVARNA I BHOIR
Objective: A reverse phase liquid chromatography method in gradient mode has been developed for quantitative determination of impurities, related substances, degradation products of Zaltoprofen and Paracetamol simultaneously. Methods: Method uses a 250 X 4.6 mm, 5µm Hypersil BDS C8 column with a mobile phase composition of ammonium acetate buffer pH 5.0: methanol in gradient mode. The flow rate was 1.0 mL min -1 and wavelength was set at 240 nm. Results: Five related substances of Zaltoprofen and three of Paracetamol were well separated with the developed method. Resolution between closely eluting peaks was more than 4.0. The method was validated for selectivity, linearity, accuracy, precision and robustness. The limit of detection and limit of quantitation for all available impurities were below 0.015% and 0.046% respectively. The method was linear in the range of limit of quantitation to 150% of specified concentration. The correlation coefficient for all components was more than 0.995. Conclusion: The stress studies showed that the method was specific, selective to study related substances of Zaltoprofen and Paracetamol simultaneously. The peak purity of analyte showed that unknown degradation products formed during stress studies did not interfere with the determination of all the studied analytes. The mass balance was achieved for Zaltoprofen and Paracetamol for degraded samples. The excipient compatibility study concluded that all the studied excipients are compatible with both drugs.