Asian Journal of Pharmaceutical Analysis

S. J. Daharwal ¹

Affiliations
1 University Institute of Pharmacy, Ravishankar Shukla University, Raipur (CG) India-492010, IN

Abstract

A simple, efficient, precise and accurate Vierodt's method have been developed for the estimation of Diazepam and Propranolal in pure and in fixed dose Combination. In this method UV spectrum of Diazepam and Propranolal were overlained which involves the formation of Simultaneous equation at maximum wavelength 241 nm and 289 nm. Both the drugs obeyed Beer's law in the concentration range 2-25 μg/ml and 1-45 μg/ml for Diazepam and Propranolal , respectively. The accuracy of the method was determined by recovery studies and was found to be 100.14±0.219 % and 100.17±0.134 % for Diazepam and Propranolal , respectively. The method was validated as per ICH guidelines. The method was found to be simple, economic, accurate and reproducible and can be used for routine analysis of Diazepam and Propranolal in pure and in fixed dose combination.

Keywords

Vierodt’s Method, Diazepam, Propranolal, ICH Guidelines

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S. J. Daharwal , Rajendra K. Jangade , Veena Devi Thakur , Bhanu Pratap Sahu

Abstract

Compatibility must be established between the active ingredient and other excipients to produce a stable efficacious, attractive and safe product.

In this report FTIR studies were performed and major peaks were determined by the (FTIR-8400S Shimadzu, Japan) will show band shift and broadening compared to the spectra of pure drug. To study the interaction between AmbroxolHCl, selected excipients (sorbitol, mannitol, sucrose).IR spectra of Ambroxol hydrochloride bands were found at 1595-1545 cm^-1 for aromatic C=C stretching, 3350-3250cm^-1 for aromatic primary amine NH stretch, 3400-3345 cm^-1 for intermolecular hydrogen bonded OH stretch and 700-600 cm^-1 for C-Br stretching. This confirms the identity of Ambroxol hydrochloride.

Keywords

Compatibility Studies, Ambroxol HCL and Excipients

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