Absorption Ratio, Derivative Spectroscopy and RP-HPLC Methods for Estimation of Guaifenesin and Ambroxol hydrochloride in Tablet

Present work describes a precise, accurate and reproducible absorption ratio, first order derivative spectroscopy and Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) methods for simultaneous estimation of Guaifenesin and Ambroxol hydrochloride. The absorption ratio (Q analysis) method was based on the measurement of absorbances at two wavelengths, one being the iso-absorptive point at 223nm (λ1) and other being λ max, 273nm (λ2) of one of the sample components. The second method was based on the use of first derivative spectroscopy, in which derivative amplitudes were measured at selected wavelengths (238 nm for guaifenesin and 255 nm for ambroxol hydrochloride), without mutual interference. In the RP-HPLC method, the drugs were resolved using a mobile phase of acetonitrile: 50mM potassium dihydrogen phosphate buffer pH adjusted to 3.2 using orthophosphoric acid (22:78 v/v) on HiQ Sil C18 (250 X 4.6 mm) 5μm column in isocratic mode. The retention times of guaifenesin and ambroxol hydrochloride were 7.5 and 9.5 min respectively. Recovery values with percentage relative standard deviation < 2 and correlation coefficient closed to 0.999 showed that the developed methods were accurate and precise. As per ICH guidelines the developed method were validated in terms of linearity, precision, accuracy, limit of detection and limit of quantification, and the results were found to be satisfactory

Author(s): Shruti D. Deshpande1, Avinash V. Deosarkar2 and Sanjay G. Walode2

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