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.
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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
