Abstract
The present work describes the development of a sensitive and economic stability indicating high performance liquid chromatographic (HPLC) method for the determination of cefpodoxime proxetil (CP) as bulk drug and as pharmaceutical formulation. Both R and S isomers of the drug were separated using Phenomenex ( mm, 5 μm particle size) ODS column with a flow rate of 1 mL min−1 and an SPD 20 A UV detector to monitor the eluate at 252 nm. The isocratic method used a mobile phase consisting of methanol and phosphate buffer of pH 4.0 in the ratio 65 : 35. The linear regression analysis data for the calibration plots showed good linear relationship with in the working concentration range of 5–100 μg mL−1. The LOD and LOQ were 53 and 160 ng mL−1, respectively. CP was subjected to stress degradation using acid, alkali, hydrogen peroxide, dry heat, wet heat, and UV light. The standard drug peaks were well resolved from the degradation products’ peaks with significantly different retention time (Rt), and the resolution factor for the R and S isomers of CP was found to be greater than 2.
Highlights
Stability indicating methods are the quantitative analytical methods that are based on the characteristic structural, chemical, or biological properties of each active ingredient of a drug product and that will distinguish each active ingredient from its degradation products so that the active ingredient content can be accurately measured [1]
The drug was found to be stable in the mobile phase. This was proved by injecting the standard solution at 0, 8, and 24 h after preparation which showed the absence of any extra peaks due to degradation, and there was not much change in the drug peak area (% RSD = 1.19) (Table 1)
The degradation kinetics of Cefpodoxime proxetil (CP) was performed by extending the stress degradation to various time intervals for acidic, alkaline, and oxidative stress, the data of which is given in Tables 6, 7, and 8 as the residual drug (%) in comparison with the zero time sample concentration, and the corresponding graphs are given in Figures 4(a) to 4(c)
Summary
Stability indicating methods are the quantitative analytical methods that are based on the characteristic structural, chemical, or biological properties of each active ingredient of a drug product and that will distinguish each active ingredient from its degradation products so that the active ingredient content can be accurately measured [1]. An ideal stability indicating method is the one that quantifies the standard drug alone and resolves it from its degradation products [3]. Stability indicating method is an analytical procedure that is capable of discriminating between the major active pharmaceutical ingredient (API) and any degradation (decomposition) product(s) formed under defined storage conditions during the stability evaluation period [4]. It is active against most Gram positive and Gram negative organisms. The development of a cost effective and safer analytical methodology that can quantify CP in pharmaceutical dosage forms and resolve the pure drug from its degradation products
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