Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Plecanatide from Bulk and Pharmaceutical Dosage Form

Abstract

The quantification of Plecanatidein both its pure and pharmaceutical formulation forms has been proposed using the straightforward, sensitive, and selective Reverse Phase High Performance Liquid Chromatography (RP-HPLC) approach. The Phenomenex Luna C₁₈ (250 x 4.6mm x 5μm) column was used for the chromatography. The mobile phase consisted of 0.1% orthophosphoric acid, acetonitrile, in the ratio of 60:40% v/v. At 254 nm, the flow rate was detected, and it was 0.9 ml/min. 2.892 minutes was determined to be the retention time. The suggested approach was verified in compliance with ICH regulations. The linearity was discovered within the 5-30 μg/mL range, correspondingly. Every validation parameter fell within the permissible bounds. Excipients did not interfere with the medication, according to the recovery trials, and the percentage of recovery was 99.70. In order to establish the drug's sensitivity, it was put through stress tests that involved exposing it to a variety of conditions, including acidic, basic, oxidative, thermal, and photolytic ones. In accordance with ICH recommendations, the proposed approach was successfully used to estimate the amount of medicine in tablet dosage form and to investigate the stability of the product under various stress situations.