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Food and Drug Administration (FDA) (1987) Guideline for Stability Studies for Human Biologics. Office of Drug Standards, New York, 3-10.

has been cited by the following article:

• TITLE: Stress Degradation Studies on Lisinopril Dihydrate Using Modified Reverse Phase High Performance Liquid Chromatography

  AUTHORS: Elsadig H. K. Adam

  KEYWORDS: Lisinopril Dihydrate, Stability, UV Light, Sun Light, High Temperature, Pharmaceutical Excipients, High Performance Liquid Chromatography

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.5 No.5, April 11, 2014

  ABSTRACT: A simple, precise, accurate and sensitive reverse phase high performance liquid chromatographic method for simultaneous estimation of lisinopril dihydrate and its degradation products occuring under different ICH prescribed stress conditions has been modified. Drug was resolved on a C18 column, utilizing modified mobile phase of tetra butyl ammonium hydroxide solution and acetonitrile. Ultra violet detection was carried out at 210 nm. The method was modified with respect to linearity, precision, accuracy, selectivity, specificity and ruggedness. The results obtained revealed that lisinopril dihydrate was an active product slightly changed under stress conditions.