Asian Journal of Pharmacy and Technology

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Development and Validation of New Analytical Method for Estimation of Anti-histamine in Tablet Dosage Form


Affiliations
1 Department of Quality Assurance, P.R. Pote Patil College of Pharmacy, Amravati – 444604, India
2 Department of Pharmaceutics, P.R. Pote Patil College of Pharmacy, Amravati – 444604, India
     

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A rapid, sensitive and accurate method for Estimation of Anti- Histamine in Tablet Dosage Form by RP-HPLC. Mobile phase was Methanol: 0.1%. Ortho phosphoric acid (80:20% v/v). Flow rate was 0.9ml/min. The detection Wavelength was 227nm. The injection volume was 20μl.The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. Linearity studies for Rupatadine Fumarate were performed (10-60μg/ml). The %RSD for accuracy found to be less than 2%. Assay was found to be 99.17 to 101.65 respectively. The range of 10-60μg /ml was selected for the linearity of a standard Rupatadine Fumarate. The 80%, 100% and 120% levels of recovery study were selected to perform the recovery study. Linearity studies for Rupatadine Fumarate was performed on (10-60μg/ml).

Keywords

RP-HPLC, Rupatadine Fumarate, Methanol, Ortho Phosphoric Acid
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  • Development and Validation of New Analytical Method for Estimation of Anti-histamine in Tablet Dosage Form

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Authors

Kalyani Gudadhe
Department of Quality Assurance, P.R. Pote Patil College of Pharmacy, Amravati – 444604, India
Mukund Tawar
Department of Pharmaceutics, P.R. Pote Patil College of Pharmacy, Amravati – 444604, India

Abstract


A rapid, sensitive and accurate method for Estimation of Anti- Histamine in Tablet Dosage Form by RP-HPLC. Mobile phase was Methanol: 0.1%. Ortho phosphoric acid (80:20% v/v). Flow rate was 0.9ml/min. The detection Wavelength was 227nm. The injection volume was 20μl.The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. Linearity studies for Rupatadine Fumarate were performed (10-60μg/ml). The %RSD for accuracy found to be less than 2%. Assay was found to be 99.17 to 101.65 respectively. The range of 10-60μg /ml was selected for the linearity of a standard Rupatadine Fumarate. The 80%, 100% and 120% levels of recovery study were selected to perform the recovery study. Linearity studies for Rupatadine Fumarate was performed on (10-60μg/ml).

Keywords


RP-HPLC, Rupatadine Fumarate, Methanol, Ortho Phosphoric Acid

References