Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF ALPRAZOLAM AND PROPRANOLOL HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Kaveri Chandrakant Dulange*, Dr. Mallinath Shankarappa Kalshetti, Zeba Mahamad Hanif Gaibu, Neha Ranjeet Gate and Shubhangi Sidram Bamgonde

ABSTRACT

A simple, rapid, precise and highly selective spectrophotometric method was developed for simultaneous estimation of Alprazolam and Propranolol hydrochloride in pure as well as tablet dosage form. The simultaneous equation method is based on measurement of absorbance at 263 nm and 289 nm as two wavelengths selected for quantification of Alprazolam and Propranolol Hydrochloride using 0.1 N HCl as a solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. A double-beam shimadzu UV-visible spectrophotometer, 1800 with a pair of 1 cm matched quartz cells was used to measure the absorbance of the solutions in developed method. The method was validated as per ICH guidelines. Linearity ranges from 5-25 μg/ml for Alprazolam and 10-50 μg/ml for Propranolol hydrochloride of the drugs. % RSD calculated was less than equal to 2 which indicates accuracy and reproducibility of the method. Recovery study indicates that these drugs could be quantified simultaneously without interference of excipient present in formulation. The developed UV spectroscopic method is suitable for the analysis of ALP and PRP in combined dosage form. The accuracy was found between 98-100% for ALP and 99-100% for PRP respectively. The precision (%RSD) was found to be 0.308 for ALP and 0.875 for PRP respectively. The LOD was found to be 0.041μg/ml for ALP and 0.094μg/ml for PRP respectively.

Keywords: Alprazolam, Propranolol Hydrochloride, Simultaneous Equation, Method Validation, UV Spectrophotometer.