A Validated New Gradient Stability-Indicating LC Method for the Analysis of Doripenem in Bulk and Injection Formulation

الملخص EN

A sensitive, precise, specific, linear, and stability-indicating gradient HPLC method was developed for the estimation of doripenem in active pharmaceutical ingredient (API) and in injectable preparations.

Chromatographic separation was achieved on C18 stationary phase with a mobile phase gradient consisting of acetonitrile, methanol, and pH 5.2 phosphate buffer.

The mobile phase flow rate was 0.8 mL/min, and the eluted compounds were monitored at 210 nm.

The method is linear over the range of 0.335 to 76.129 µg/mL.

The correlation coefficient was found to be 0.999.

The numbers of theoretical plates and tailing factor for doripenem were 53021 and 0.9, respectively.

Doripenem was subjected to the International Conference on Harmonization (ICH) prescribed hydrolytic (acid, base, and neutral), oxidative, photolytic, and thermal stress conditions.

Among all the above-mentioned conditions, the drug was found to be stable under photolytic degradation.

Peak homogeneity data for doripenem in the chromatograms from the stressed samples obtained by use of the photodiode array detector demonstrated the specificity of the method for analysis of doripenem in presence of the degradation products.

The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, and robustness.