THE ICH GUIDELINES IN PRACTICE: FORCED DEGRADATION STUDIES OF DORIPENEM BY AN LC-MS COMPATIBLE RP-HPLC METHOD
AbstractIn this manuscript, a fast, stability-indicating RP-HPLC method with UV detection was developed and validated to quantify doripenem in the bulk drug and its injectable formulation. The analysis was performed using Phenomenex (250 x 4.6mm, 5µm) ODS column with a flow rate of 1 mL min–1 and a SPD 20 A UV detector to monitor the eluate at 316 nm. The mobile phase was acetonitrile and 10 mM ammonium formate (pH=3.5) in the ratio 35:65, in isocratic mode. The linearity range is 25–250 μg mL-1 and the linear regression analysis data for the calibration plot showed good linear relationship with R2 = 0.9999. The LOD and LOQ were 213 and 638 ng mL-1 respectively. The stress conditions employed include acid, alkali, water, hydrogen peroxide, dry heat and UV light. The drug peak was well resolved from the degradation products’ peaks; hence, the method can be used to analyze stability samples also.
Article Information
21
3421-3427
631 KB
355
English
IJPSR
Ceema Mathew *, Shashikala Metri, Gorja Ashok and Devilal Jarpula
Gokaraju Rangaraju College of Pharmacy, Osmania University, Bachupally, Hyderabad, Telangana, India.
nirujose@gmail.com
07 November 2022
23 March 2023
01 May 2023
10.13040/IJPSR.0975-8232.14(7).3421-27
01 July 2023
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