Development and Validation of an HPTLC Method for Simultaneous Estimation of Etofylline and Salbutamol

Department of Pharmaceutical Quality Assurance, School of Pharmacy, RK University, Rajkot - 360020, Gujarat ( INDIA )

Published online: 21 January 2026

Abstract

A precise, robust, and cost-effective High-Performance Thin Layer Chromatography (HPTLC) method was developed and validated for the simultaneous estimation of Salbutamol and Etofylline in bulk and combined pharmaceutical dosage forms. Chromatographic separation was achieved on precoated silica gel 60 F254 TLC plates using a mobile phase consisting of toluene, ethyl acetate, and methanol in an optimized ratio. The detection was performed densitometrically at an appropriate wavelength using CAMAG TLC Scanner. The method demonstrated excellent linearity over the concentration range of 100-600 ng/band for both drugs, with correlation coefficients (R²) exceeding 0.998. Validation was carried out in accordance with ICH Q2(R2) guidelines, covering parameters such as accuracy, precision, linearity, limit of detection (LOD), limit of quantification (LOQ), specificity, robustness, and ruggedness. The recovery values were found to be within acceptable limits, confirming the method's accuracy. The proposed HPTLC method can be effectively applied for routine quality control and analysis of Salbutamol and Etofylline in combined pharmaceutical formulations, offering advantages such as reduced solvent consumption, lower cost, and faster analysis time compared to conventional methods.