Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF SAROGLITAZAR IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY USING RP-HPLC

Swarangi Mohana, Renjarla Ashithi, Cheviti Sowmya, Survi Sowmya, Sabavath Sravani, Bavaji Keerthi*

ABSTRACT

Objective: A rapid, sensitive, selective, and reproducible reversed-phase high-performance liquid chromatographic method has been developed and validated for the determination of Saroglitazar (BRG), is an anaplastic lymphoma kinase inhibitor used to treat anaplastic lymphoma kinase positive metastatic non-small cell lung cancer. Methods: The chromatographic separation was carried out in an isocratic mode on a Phenomenex Luna C18, 100A, 5µm, 250mm x 4.6mm i.d. column with a mobile phase consisting of methanol and acetonitrile containing in the ratio of 80:20% v/v at a flow rate of 1.0 ml/min. The run time was maintained for 8.0 min and detection was monitored at 271 nm. Results: The calibration plot was linear over the concentration range of 6–16 μg mL−1 with limits of detection and quantification values of 0.5 and 0.15ng mL−1 respectively. The mean % assay of marketed formulation was found to be 99.85%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%. Conclusion: This method was found to be simple, selective, precise, accurate, and cost-effective. Hence, the method can be successfully applied to analyze the Saroglitazar in bulk form and marketed pharmaceutical dosage forms.

Keywords: Saroglitazar, RP-HPLC, Method Development, Validation, Precision.