Stability Studies and Developed Validated High Performance Liquid Chromatography Method for Analysis of Cefixime Trihydrate And Lisinopril Dihydrate

Abstract

Cefixime trihydrate and lisinopril dihydrate were subjected to different ICH, USP, and Sudanese environment prescribed stress conditions of thermal stress, sun light ,UV light and hydrolysis as prescribed in ICH and USP. A simple, precise, accurate, linear, and sensitive reverse phase high performance liquid Chromatographic method was developed and used for simultaneous estimation of cefixime trihydrate and lisinopril dihydrate and its degraded products which occur under these stress conditions. The solid drug of cefixime trihydrate turned intense brownish on exposure to sun rays for six months and turned white yellow on exposure to UV light; in total two major degradation products were detected by HPLC. xxii For establishment of stability indicating assay, the reaction solution in which different degradation products were formed by thermal and photolysis stress and the separation was optimized by HPLC condition and PTLC techniques. The acidic and alkaline hydrolyses of cefixime trihydrate increase by increasing the concentration of acidity, alkalinity and temperature. The results obtained revealed that, with increase of the concentration of cefixime trihydrate solution there was decrease in the photo thermal decomposition reaction rate (K).In high pH value there was an increase in the photo thermal decomposition rate (K). The results proved that the use of some pharmaceutical excipients for drug preparation leads to the stabilization of the drug against photo thermal decomposition. Other excipients lead to increasing the rate of photo thermal decomposition. All the photo thermal reaction of cefixime trihydrate in aqueous media was found to follow first order reaction kinetics. An acceptable separation was achieved using validated HPLC for analysis of degraded products. In this work, RP HPLC method was analysis of cefixime trihydrate and its degraded products, which establishment a linear response of the drug over a concentration range, correlation coefficient (r) 0.9996.The mean values for slope, intercept are reported. Validation of the methods was done by studying various parameters of linearity, precision, accuracy, specificity, and selectivity. The developed validated method was successfully applied to determination of cefixime trihydrate and its decomposed products; it can be very useful as alternative method instead of performing the stability studies. In this work, the stability of linsinopril dihydrate was studied under stress conditions. The solid drug of linsinopril dihydrate does not change intense on exposure to sun rays for six months and turned to white yellow on exposure to UV light, no degradation products were detected by HPLC.The result ‫‪obtained revealed that lisinopril dihydrate was active product stable under this‬‬‫.‪stress conditions‬‬