Tue, 21 Nov 2017

Analytical Method Development and Method Validation for the Estimation of Irbesartan in Tablet Dosage Form by HPLC Method

Nandagopal Anitha1*, Tirunagari Mamatha1, Ethirajulu ThirumalaiRajan2Giri Mrudul3, Parveen Sultana1

1. Sultan-Ul-Uloom College of Pharmacy, Road No: 3, Banjara Hills, Hyderabad, 500 034, Andhra Pradesh, India.

2. Dr.Reddys Laboratories, Bachupally, Hyderabad, Andhra Pradesh, India.

3.Krupanidhi College of Pharmacy, Bangalore, Karnataka


ABSTRACT

A simple, sensitive and specific HPLC method with UV detection was developed for the estimation of irbesartan in tablet dosage form. Separation was achieved by Lithosphere 100 RP-18e, 5µ column having 250x4.0 mm internal diameter with mobile phase containing phosphate buffer and acetonitrile in 50:50 (v/v) with an ambient temperature. The flow rate was 0.8mL min-1 and eluent was monitored at 220 nm. The proposed method was found to be rectilinear over theconcentration range of 20µg/ml to 60µg/ml. This method was validated for system suitability, Specificity, Linearity, Precision, Accuracy, Range, Stability studies, Ruggedness, Robustness and Filter validation.  The results of all the validation parameters were well within their acceptance values. Therefore the proposed method can be used for routine analysis of estimation of Irbesartan in its tablet formulation

Keywords: Irbesartan, Tablet formulation, Antihypertensive, HPLC, Validation


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