Mohammed Sabah Kadhi, Reem Al-Uobody, Sarmad Dheyaa Noori, H. N. K. AL-Salman

Pharmaceutical analytical determination of doxepin hydrochloride in tablets using an HPLC-UV method

 

2026-06-01

Doxepin hydrochloride belongs to a group of substances called tricyclic antidepressants. Accurate quantitative estimation is very important for appropriate dosing. However, methods currently used for selective, sensitive and economical collection, as well as quality-controlled methodologies are not identical. The goal of this article is to develope and validate a straightforward, easy, accurate, and cost-effective HPLC-UV technique for doxepin hydrochloride quantification in tablet dosage form. A C18 column (250 mm × 4.6 mm, 5 µm) with mobile phase acetonitrile: phosphate buffer pH 3.0 (70 : 30, v/v) at a flow rate of 1.0 mL/min was used to create an isocratic technique. Detection was performed at a UV wavelength of 295 nm. It was discovered that the method was compliant with ICH Q2(R1). The authors’s technique demonstrated good linearity (r 2 = 0.9998) between 10 and 100 µg/mL. The daily accuracy expressed as a percentage RSD was less than 2.0. The precision of the results for recovery ranged from 98.5 to 101.2. The detection and quantification limits were determined to be 0.8 g per milliliter and 2.5 µg, respectively.

A less expensive and less time consuming HPLC-UV method for the analysis of various pharmaceutical compounds can be used to determine the quality control of doxepin hydrochloride in tablets on routine basis.

Keywords: Doxepin hydrochloride, HPLC-UV, method validation, pharmaceutical analysis, quality control, tricyclic antidepressants, stability-indicating method.

© Farm Pol, 2025, 81(11): 655–661