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Development and Validation of a RP-HPLC Method for Estimatio | 25725

International Journal of Pharmacy Teaching & Practices

ISSN - 1986-8111

Abstract

Development and Validation of a RP-HPLC Method for Estimation of Nitrendipine in Tablet Dosage Form

Sumeet Dwivedi and Debadash Panigrahi

A simple, selective, rapid, precise, sensitive and accurate HPLC method has been developed for the estimation of nitrendipine in tablet dosage form. The method was carried out on a Phenomenox C-18 column (250 mm x 4.6 mm, 5 μm) using acetonitrile, methanol and water (40:30:30 v/v) as mobile phase( pH was adjusted to 3.0 with orthophosphoric acid) at a flow rate of 1ml/min . Detection was performed by UV detector at 232 nm. Total run time was 10 minutes and the drug was eluted at a retention time of 2.619min. The developed method was validated for linearity, precision, accuracy, specificity, sensitivity, limit of detection and limit of quantitation in accordance with ICH. The linearity range was 5 to 30 μg/ml. The recovery was within the range of 99.14-101.21 and the coefficient of variance was < 2%. The inter day and intraday precision were 0.746 and 0.981 respectively. The high percentage recovery and low coefficient of variation confirm the suitability of the method for estimation of nitrendipine in tablet dosage form.

 
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