2014Journal of Pharmaceutical and Scientific InnovationRequires access

DEVELOPMENT AND VALIDATION OF UV AND RP-HPLC METHODS FOR THE ESTIMATION OF CEFTRIAXONE SODIUM IN PHARMACEUTICAL FORMULATIONS

Shanta Kumari Adiki, Baishakhi Dey, Nureddin AA Arebi, Fauzi El Melad, Prakash Katakam, Babu Rao Chandu

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Abstract

The current research paper reports a validated UV and RP - HPLC method fo r routine estimations of CFTX in bulk and unit dosage formulations. For the UV estimation of CFTX, using ammonium acetate buffer as the solvent, λ max was set at 241.5 nm and linearity range obtained in the concentration range of 2 - 10 µg/mL. The optimized R P - HPLC conditions for CFTX estimation were obtained with isocratic separation mode in a C 18 inertsil column (150 mm × 4.6 mm, 3 μm) using a degassed mixture of buffer: methanol in the ratio of 74:26, injection volume (20 µL), flow rate (1 mL/min) and ru n t ime (20 min utes ), at ambient column temperature with UV detector set at 254 nm. The linearity of the method was demonstrated over the concentration range of 80 - 120 µg/mL. The percent assay of CFTX determined by UV and RP - HPLC method were 99.8 ± 0.001 and 1 01.5 ± 0.001 respectively. The recovery CFTX deter mined by UV and RP - HPLC were 99 .6 - 99.8 % and 101.1 % respectively with % RSD values of peak areas 0.2 and 0.3 respectively. Values of all other parameters of method validations in both methodologies were wi thin the acceptance limits.

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What this paper is about

The current research paper reports a validated UV and RP - HPLC method fo r routine estimations of CFTX in bulk and unit dosage formulations. For the UV estimation of CFTX, using ammonium acetate buffer as the solvent, λ max was set at 241.5 nm and linearity range obtained in the concentration range of 2 - 10 µg/mL. The optimized R P - HPLC conditions for CFTX estimation were obtained with isocratic separation mode in a C 18 inertsil column (150 mm × 4.6 mm, 3 μm) using a degassed mixture of buffer: methanol in the ratio of 74:26, injection volume (20 µL), flow rate (1 mL/min) and ru n t ime (20 min utes ), at ambient column temperature with UV detector set at 254 nm. The linearity of the method was demonstrated over the concentration range of 80 - 120 µg/mL. The percent assay of CFTX determined by UV and RP - HPLC method were 99.8 ± 0.001 and 1 01.5 ± 0.001 respectively. The recovery CFTX deter mined by UV and RP - HPLC were 99 .6 - 99.8 % and 101.1 % respectively with % RSD values of peak areas 0.2 and 0.3 respectively. Values of all other parameters of method validations in both methodologies were wi thin the acceptance limits.

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Available abstract

The current research paper reports a validated UV and RP - HPLC method fo r routine estimations of CFTX in bulk and unit dosage formulations. For the UV estimation of CFTX, using ammonium acetate buffer as the solvent, λ max was set at 241.5 nm and linearity range obtained in the concentration range of 2 - 10 µg/mL. The optimized R P - HPLC conditions for CFTX estimation were obtained with isocratic separation mode in a C 18 inertsil column (150 mm × 4.6 mm, 3 μm) using a degassed mixture of buffer: methanol in the ratio of 74:26, injection volume (20 µL), flow rate (1 mL/min) and ru n t ime (20 min utes ), at ambient column temperature with UV detector set at 254 nm. The linearity of the method was demonstrated over the concentration range of 80 - 120 µg/mL. The percent assay of CFTX determined by UV and RP - HPLC method were 99.8 ± 0.001 and 1 01.5 ± 0.001 respectively. The recovery CFTX deter mined by UV and RP - HPLC were 99 .6 - 99.8 % and 101.1 % respectively with % RSD values of peak areas 0.2 and 0.3 respectively. Values of all other parameters of method validations in both methodologies were wi thin the acceptance limits.

Key concepts: Ceftriaxone, Chromatography, Sodium, Chemistry, High-performance liquid chromatography, Pharmacology, Mathematics, Medicine

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DEVELOPMENT AND VALIDATION OF UV AND RP-HPLC METHODS FOR THE ESTIMATION OF CEFTRIAXONE SODIUM IN PHARMACEUTICAL FORMULATIONS — Research Paper | ScholarLens