Sadhana Rajput, Prachi Bhamre, Satish Bambhrolia

Abstract

A simple, accurate, precise, specific, economical and fast gradient HPLC-PDA method has been developed and validated for the simultaneous determination of Ambroxol hydrochloride (AML), Potassium clavulanate (PC) and Amoxicillin trihydrate (AMX) in bulk drugs and laboratory prepared synthetic mixture. Effective chromatographic separation was achieved on a Phenomenex Luna C18 (250 mm×4 mm i.d., 5μm particle size) column with gradient elution of mobile phase solvent A (methanol: 0.01 M phosphate buffer (pH 3.0) (14:86)), and solvent B (methanol) and at a detection wavelength of 220 for PC, AMX and AML. The retention times for PC, AMX, and AML were 4.26, 5.15 and 6.25 min respectively. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to linearity, range, precision, accuracy, specificity, robustness, detection limit and quantification limit as per ICH guideline Q(2). The validated HPLC method was applied to the analysis of synthetic mixture of three drugs prepared in laboratory in which the analytes were successfully quantified with good recovery values and no interfering peaks were encountered from the excipients.