Asian Journal of Research in Chemistry

S. Kathirvel ¹, S. V. Satyanarayana ², G. Devalarao ³

Affiliations
1 Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, A.P, IN
2 Department of Chemical Engineering, JNTU College of Engineering, Anantapur, A.P, IN
3 Department of Pharmaceutical Analysis, K.V.S.R Siddhartha College of Pharmaceutical Sciences, Vijayawada, A.P, IN

Abstract

The present work describes a simple, precise and accurate HPLC method for estimation of darifenacin hydrobomide in bulk and in tablet dosage form. The separation was achieved by using Waters Sunfire C₁₈(4.6 X 250 mm) 5μm particle size column. The mobile phase consisted of 0.02M potassium dihydrogen phosphate buffer pH 7 adjusted with triethylamine: acetonitrile: methanol in the ratio of 40:30:30(v/v/v). Detection was carried out at 280 nm. The retention time of darifenacin hydrobromide was found to be 4.2 min respectively. The Limit of detection and limit of Quantification was found to be 2.112 μg/mL and 6.400 μg/mL respectively. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (10-100 μg/mL), precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of darifenacin hydrobromide in bulk and in tablet dosage form.

Keywords

Darifenacin Hydrobromide, HPLC, Method Development, Validation.

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S. Kathirvel ¹, G. Devala Rao ², S. V. Satyanarayana ³

Affiliations
1 Dept. of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur-2, A.P, IN
2 Dept. of Pharmaceutical Analysis, KVSR Siddhartha College of Pharmacy, Vijayawada-10, A.P, IN
3 Dept. of Chemical Engineering, JNTU College of Engineering, Anantapur-515002, A.P, IN

Abstract

A simple, sensitive and economical UV spectrophotometric method has been developed for the determination of Risperidone in bulk and tablet dosage forms. Risperidone is an anti-psychotic drug, which shows maximum absorbance at 238 nm in 0.1 N HCl. Beer’s law was obeyed in the concentration range of 5-30 μg/ml with correlation coefficient of 0.9999.The standard plot clearly showed a straight line passing through the origin. The results of analysis were validated statistically and by recovery studies and found to be satisfactory. The proposed method was extended to pharmaceutical formulations and there was no interference of additives and excipients.

Keywords

Risperidone, UV Spectrophotometric, Tablet Dosage Form.

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