Abstract :
The objective of the present work is to develop a simple, precise, accurate, validated stability indicating RPHPLC method for the determination of Phenazone and Lidocaine hydrochloride in bulk and tablet dosage form. The HPLC separation was achieved on Agilent TC C18 (2) 250 x 4.6 mm, 5 m column using mobile phase composition of phosphate buffer pH 2.5, acetonitrile, Methanol 70:20:10 (V/V/V). Flow rate was maintained at 1.5 ml/min at an ambient temperature. Quantification was achieved with ultraviolet detection at 230 nm. The retention time obtained for Lidocaine hydrochloride was at 7.2 min of and Phenazone was at 10.1 min. The result obtained with the detector response was found to be linear in the concentration range of 50-150 mg/ml for Phenazone and 10-70 mg/ml for Lidocaine Hydrochloride. The reliability and analytical performance of the proposed methods, including linearity, range, precision, accuracy, detection and quantitation limits, were statistically validated. When of Phenazone and Lidocaine hydrochloride was subjected to different stress conditions; the proposed methods could effectively separate the drug from its degradation products, and were thus considered as good stability-indicating procedures. It is concluded that this method can be applied for routine quality control of Phenazone and Lidocaine Hydrochloride in dosage forms as well as in bulk drug.
Keyword :
Phenazone, Lidocaine hydrochloride, Lidophen ear drop, Method development and validation, Stability indicating.