DOI: https://doi.org/10.36347/sajp.2025.v14i09.002

Pages: 203-207

A new UV-Spectrophotometer method is developed for measurement of Ammonia content using Nessler reagent for semisolid drug products that containing D02AE01 active substance. There are limited published studies evaluating ammonia content for semisolid drug products. The semisolid products have a complex sample matrix which the phases include immiscible or partially miscible liquids and emulsifying agents. The presence of these excipients makes method development more difficult. The aim of our study was to develop and validate a new method for the determination of ammonia content with UV-Spectrophotometer. Meanwhile, an alternative method to the ammonia method available in the British Pharmacopoeia Urea Cream monograph is intended to be promoted. Liquid-liquid phase extraction was used as a preparation technique in semisolid samples. This UV spectrophotometer method is easy applicable and has low cost to perform the analysis. There are meaningful reasons for preferring the UV Spectrophotometer. This instrument gives extremely accurate measurement and it is possible to make measurements quickly, also data analysis is simple. This method was validated for specificity, linearity and range, precision, accuracy and robustness. All results meet the regulatory requirements and this confirmed that the method is suitable for determination of ammonia content for semisolid pharmaceutical dosage forms.