Mon, 18 Dec 2017

New Stability Indicating Validated RP-HPLC Method for Simultaneous Estimation of Irbesartan and Atorvastatin Bulk and Combined Tablet Dosage Form

Gandla Kumara Swamy1*, J.V.L.N.Seshagiri Rao3, JM Rajendra Kumar2

1. Research scholar, Department of Pharmaceutical Analysis, Jawaharlal Nehru Technological University Kakinada, Kakinada - 533003-Andhra Pradesh, India.

2. Mylan Laboratories Limited, Plot no 31, 32, 33&34-A, Anrich Industrial Estate, Bollaram, Medak (Dist) 502325, India.

3. Srinivasarao College Of Pharmacy, Pothinamallayyapalem, Madhurawada, Visakhapatnam-500041. A.P. India.


ABSTRACT

The present study is a simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Irbesartan and Atorvastatin from bulk and formulations. The proposed method was developed by HPLC Shimadzu Separation Module with PDA/UV detector connected to Empower-2 software using Inertsil C18 ODS (4.6 x 250mm, 5mm) with an injection volume of 20 µl was injected and eluted with a mobile phase composition of Methanol: Acetonitrile (50:50), which is pumped at a flow rate of 0.8ml/min and detected by PDA detector at 245nm. Ambient column temperature has maintained. The total run time was 10mins.The retention time of Irbesartan and Atorvastatin were found to be 2.9 min. and 4.1 min respectively. Linearity was observed in the concentration range of 0.2-0.8mg/ml for Irbesartan and Atorvastatin respectively with correlation coefficient 0.999 for both the drugs. Percent recoveries obtained for both the drugs were98.0-101.50%, respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed IRB be used for the routine analysis of Irbesartan and Atorvastatin from their combined dosage form.

Keywords: Irbesartan and Atorvastatin; Isocratic Elution; RP- HPLC Method; Forced degradation studies; PDA Detector; Tablet dosage forms.


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