Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Bromhexine Hydrochloride and Phenylephrine Hydrochloride in their Combined Pharmaceutical Dosage Form

Dharmesh Mevada; Krutika Bhalodiya; Brijesh Maniar; Ketan Dadhania; Shital Faldu

Dharmesh Mevada Smt. R. D. Gardi B. Pharmacy College
Krutika Bhalodiya Smt. R. D. Gardi B. Pharmacy College
Brijesh Maniar Smt. R. D. Gardi B. Pharmacy College
Ketan Dadhania Smt. R. D. Gardi B. Pharmacy College
Shital Faldu Smt. R. D. Gardi B. Pharmacy College

Keywords: Bromhexine, Phenylephrine, First Order Derivative Spectrophotometric Method

Abstract

UV Spectrophotometric method has been developed for simultaneous estimation of Bromhexine HCl (BHX) and Phenylephrine HCl (PLE) in bulk drug and in their combined Pharmaceutical dosage form by first order derivative. This method utilizes methanol as a common solvent and λmax of BHX and PLE selected for analysis was found to be at 241 nm (at ZCP of PLE) and 233 nm (at ZCP of BHX) respectively. Linearity was observed in the concentration range of 5-30 μg/ml for BHX (r²= 0.999) and 10-60 μg/ml for PLE (r²= 0.998). The accuracy and precision were determined and found to comply with ICH guidelines. This method showes good reproducibility and recovery with % RSD in the desired range. Developed method was applied for marketed formulation. The results were found to be within acceptance criteria according to ICH guideline. This method was simple, rapid, accurate, Precise and sensitive.