Asian Journal of Pharmaceutical Analysis

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Development and Validation of Simultaneous Estimation Method for Amoxycillin Trihydrate and Tinidazole in Tablet Dosage Form by RP-HPLC


Affiliations
1 Department of Quality Assurance, Lachoo Memorial College of Science and Technology, Pharmacy wing, Jodhpur, Rajasthan–342003, India
     

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A reversed phase high performance liquid chromatography method was developed and validated to measure Amoxycillin Trihydrate and Tinidazole at single wavelength (240 nm) in order to perform assay of drug from tablet formulation. The isocratic method was developed on Hiq Sil, C-18, V size (250mm ∗4.6mm, 5μ) column with disodium hydrogen phosphate buffer (pH 3.6): acetonitrile mobile phase in ratio of 30:70 delivered at 1.0 ml/min. The selected chromatographic conditions were found to separate amoxycillin trihydrate (Rt=1.903 min) and tinidazole (Rt=4.410 min) having a resolution of 7. Results of the analysis were validated statistically as per ICH guidelines. The percentage recoveries for amoxycillin trihydrate and tinidazole ranged from 99.85% and 99.75% respectively. The limit of detection was found to be 1.063μg/ml and 0.5535μg/ml for amoxicillin trihydrate and tinidazole respectively. Limit of quantification was found to be 3.189μg/ml and 1.660μg/ml for amoxycillin trihydrate and tinidazole respectively. All results were acceptable and confirmed suitability of the method for its intended use in routine quality control and assay of drugs.

Keywords

Amoxicillin Trihydrate, Method Development, RP-HPLC, Tinidazole, Validation
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  • Development and Validation of Simultaneous Estimation Method for Amoxycillin Trihydrate and Tinidazole in Tablet Dosage Form by RP-HPLC

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Authors

Renu Solanki
Department of Quality Assurance, Lachoo Memorial College of Science and Technology, Pharmacy wing, Jodhpur, Rajasthan–342003, India
Badri Prakash Nagori
Department of Quality Assurance, Lachoo Memorial College of Science and Technology, Pharmacy wing, Jodhpur, Rajasthan–342003, India
Mahendra Kumar Naval
Department of Quality Assurance, Lachoo Memorial College of Science and Technology, Pharmacy wing, Jodhpur, Rajasthan–342003, India
Joytosh Banerjee
Department of Quality Assurance, Lachoo Memorial College of Science and Technology, Pharmacy wing, Jodhpur, Rajasthan–342003, India

Abstract


A reversed phase high performance liquid chromatography method was developed and validated to measure Amoxycillin Trihydrate and Tinidazole at single wavelength (240 nm) in order to perform assay of drug from tablet formulation. The isocratic method was developed on Hiq Sil, C-18, V size (250mm ∗4.6mm, 5μ) column with disodium hydrogen phosphate buffer (pH 3.6): acetonitrile mobile phase in ratio of 30:70 delivered at 1.0 ml/min. The selected chromatographic conditions were found to separate amoxycillin trihydrate (Rt=1.903 min) and tinidazole (Rt=4.410 min) having a resolution of 7. Results of the analysis were validated statistically as per ICH guidelines. The percentage recoveries for amoxycillin trihydrate and tinidazole ranged from 99.85% and 99.75% respectively. The limit of detection was found to be 1.063μg/ml and 0.5535μg/ml for amoxicillin trihydrate and tinidazole respectively. Limit of quantification was found to be 3.189μg/ml and 1.660μg/ml for amoxycillin trihydrate and tinidazole respectively. All results were acceptable and confirmed suitability of the method for its intended use in routine quality control and assay of drugs.

Keywords


Amoxicillin Trihydrate, Method Development, RP-HPLC, Tinidazole, Validation

References