Development of an RP-HPLC Method for the Simultaneous Estimation of Propranolol Hydrochloride and Diazepam in Combined Dosage form

Abstract:

A simple, efficient, and reproducible RP-HPLC method for the simultaneous determination of propranolol hydrochloride and diazepam in bulk and in pharmaceutical formulations has been developed and validated. The separation was carried out on Waters C18 (250 ×4.6 mm i.d, 5 μ) column using acetonitrile: 0.4 % potassium dihydrogen ortho phosphate (adjusted to pH 3.52 with ortho phosphoric acid) in the ratio of 60:40 v/v as eluent. The flow rate was 1 ml/min and effluent was detected at 229 nm. The retention time of propranolol hydrochloride and diazepam were 2.330 and 6.663 min. respectively. The linear dynamic range was 2-24 μg/ml and 0.25- 3.0 μg/ml for propranolol hydrochloride and diazepam, respectively. Percentage recoveries for propranolol hydrochloride and diazepam were 100.03 and 99.72 %, respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise and robust for the simultaneous determination of propranolol hydrochloride and diazepam in tablet dosage forms.

Keywords: Propranolol hydrochloride, Diazepam, and Simultaneous determination