Stability indicating RP-HPLC method for simultaneous estimation of salbutamol sulphate and guaifenesin

Present work describes a precise, accurate and reproducible RP-HPLC method for simultaneous estimation of salbutamol sulphate and guaifenesin. The drugs were resolved using a mobile phase of acetonitrile: 50 mM disodium hydrogen phosphate buffer containing 0.1% triethylamine (36:64 v/v pH 3.0) on an Inertsil, ODS-3V C18 (250 X 4.6 mm), 5μm column in isocratic mode. Recovery values of 99.82-101.07 %, percentage relative standard deviation of <1.81 and correlation coefficient of 0.998–0.999 shows that the developed methods were accurate and precise. For stability study, the drug was exposed to the stress conditions such as acid, base, oxidation, neutral and sunlight. As per ICH guidelines the results of the analysis were validated in terms of specificity, limit of detection, limit of quantification, linearity, precision and accuracy and were found to be satisfactory. These methods can be employed for the routine analysis of syrup containing salbutamol sulphate and guaifenesin.
Author(s): Sanjay G. Walode, Shruti D. Deshpande and Avinash V. Deshpande

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