Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ETIZOLAM AND PROPRANOLOL HCL IN BULK FORM AND MARKETED FORMULATION

Pratap Kumar Patra* and Sura Gnanaraj

ABSTRACT

A new analytical simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the simultaneous determination of Etizolam and Propranolol HCL in bulk and pharmaceutical dosage form dosage form. The chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5m, 15cmx4.6mm i.d. i.d. column with UV detection at 255nm and Methanol: Phosphate buffer (0.02M) with 55:45 (pH-2.6) ratios at a flow rate of 1.0 ml/ min. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines. The method was linear over the range of 0-14μg/ml for Etizolam and 0-28μg/ml for Propranolol HCL. The recovery was in the range of 98% to 102%. The LOD was found to be 0.06 g/ml and 0.09 g/ml for Etizolam and Propranolol HCL respectively. The LOQ was found to be 0.18 g/ml and 0.27 g/ml for Etizolam and Propranolol HCL. The proposed method was successfully applied to the simultaneous determination of Etizolam and Propranolol HCL in bulk and pharmaceutical dosage form.

Keywords: RP-HPLC, Etizolam and Propranolol HCL, ICH Guidelines, Accuracy, Precision.