Stress Degradation Behavior of Desipramine Hydrochloride and Development of Suitable Stability-Indicating LC Method

• Published in: Chromatographia Vol. 68; no. 11-12; pp. 919 - 926
• Main Authors: Thiyagarajan, Thilak Kumar, Rao, B. Mallikarjuna, Vukkum, Pallavi, Nasser, Jamal Abdul, Singh, Abhishek, Deshpande, Girish R
• Format: Journal Article
• Language: English
• Published: Wiesbaden Wiesbaden : Vieweg Verlag 01.12.2008; Vieweg Verlag; Springer
• Subjects: Analysis; Analytical Chemistry; Biological and medical sciences; Chemistry; Chemistry and Materials Science; Chromatography; General pharmacology; Laboratory Medicine; Medical sciences; Original; Pharmacology. Drug treatments; Pharmacy; Proteomics; Column liquid chromatography; Stability-indicating methods; Desipramine hydrochloride; Forced degradation; Chemical analysis; Impurity; Desipramine; Psychotropic; Chemical stability; HPLC chromatography; Purity control; Thermal stability; Bulk material; Antidepressant agent; Quantitative analysis; Validation; Elution; Gradient; Tricyclic compound; Reversed phase chromatography; Ultraviolet detector; Quality control; Photochemical stability; Degradation product; Dibenzazepine derivatives
• ISSN: 0009-5893; 1612-1112
• DOI: 10.1365/s10337-008-0825-x

A simple reverse phase liquid chromatographic method was developed for the quantitative determination of desipramine hydrochloride and its related impurities in bulk drugs which is also stability-indicating. During the forced degradation at hydrolysis, oxidative, photolytic and thermal stressed conditions, the degradation results were only observed in the oxidative stress condition. The blend of the degradation product and potential impurities were used to optimize the method by an YMC Pack Pro C₁₈ stationary phase. The LC method employs a linear gradient elution with the water-acetonitrile-trifluoroacetic acid as mobile phase. The flow rate was 1.0 mL min⁻¹ and the detection wavelength 215 nm. The stressed samples were quantified against a qualified reference standard and the mass balance was found close to 99.0% (w/w) when the response of the degradant was considered to be equal to the analyte (i.e. desipramine). The developed RP-LC method was validated in agreement with ICH requirements.