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Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAROGLITAZAR IN BULK AND TABLET DOSAGE FORM

P. Sripriya*, G. Naga Sowjanya, A. Ajitha, and V. Uma Maheswara Rao

ABSTRACT

A simple, precise, rapid and reproducible stability indicating RP -
HPLC method was developed and validated for the determination of
Saroglitazar in pharmaceutical dosage forms. Chromatography was
performed on a ODS C18 (ODS) column (250 mm X 4.6 mm i.d.
Particle size 5) Acetonitrile: Triethylamine buffer pH4.6:Methanol
(70:20:10 v/v) as a mobile phase at a flow rate of 1 ml/ min. The
detection was carried out at 292 nm using analytical Tech. PDA 996
Detector. The obtained calibration curve was linear in the
concentration range of 10-50μg/ml. The limit of detection and
quantification was found to be 1.81 g/ml and 5.5 g/ml respectively.
It was found that the amount of Saroglitazar present in the Tablet
formulation was 100%. The method was validated statistically using
SD, %RSD and SE and the values are
found to be within the limits. The recovery studies were performed and the percentage
recovery was found to be 100 %.

Keywords: Saroglitazar, RP-HPLC, PDA detection, Isocratic Elution;Tablet dosage forms.


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