A New RP-HPLC Method Development and Validation for Simultaneous Estimation of Salbutamol Sulphate and Theophylline in Pharmaceutical Syrup Dosage Form

Author(s)

Kowsar, B. S., Rubesh, K. S., Duganath, N., Bharath, R. K., Devanna, N.

Author's Affiliation

Abstract

A simple, rapid reverse phase high-performance liquid chromatographic method was developed and validated for the simultaneous estimation of salbutamol sulphate and theophylline in a cough syrup formulation marketed as Theoasthalin. Chromatographic separation was done using Phenomenex LunaC18 column having dimension of 4.6×250mm having particle size of 5µm, with mobile phase consisting of acetonitrile and water (40:60 %v/v), flow rate was adjusted to 1.0 ml/min and detection wavelength at 230nm. The retention times of salbutamol sulphate and theophylline was found to be 2.1 and 3.5mins. The Proposed method has been validated for linearity, range, precision, accuracy and robustness were within the acceptance limit according to ICH Q2B guidelines. Quantification of the components in actual syrup formulations was calculated against the responses of freshly prepared external standard solutions. Linearity for salbutamol sulphate and theophylline was found in range of 0.25ppm-1.5ppm & 12.5ppm-75ppm and correlation coefficient was found to be  0.999 and 0.999, %RSD for intermediate precision was found to be 0.67 and 0.49 and for system precision 0.58 and 0.57 and for repeatability was 0.67 and 0.49.The percentage purity of salbutamol sulphate and theophylline was found to be 99.70and 99.54%v/v respectively.The method was found to be robust even by change in the mobile phase ±5% and in less flow condition.

Keywords

Salbutamol sulphate and Theophylline, RP-HPLC, Method validation

Cite This Article

Kowsar, B. S., Rubesh, K. S., Duganath, N., Bharath, R. K., Devanna, N. (2013). A New RP-HPLC Method Development and Validation for Simultaneous Estimation of Salbutamol Sulphate and Theophylline in Pharmaceutical Syrup Dosage Form. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(3), 218-226.