MUMBAI, India, Sept. 5 -- Intellectual Property India has published a patent application (202441012113 A) filed by Ratnakar Cherukupally; Badikela Rama Krishna; T K Hima Bindu; Pranaya Pakir; T Ashwini; Kosika Sandeep; M Sesha Madhavi; and Dr. Shaik Harun Rasheed, Qutbullapur, Telangana, on Feb. 21, 2024, for 'development and validation of stability indicating method of immunotherapy (ctla-4) agent by reverse phase ultra performance liquid chromatography.'

Inventor(s) include Ratnakar Cherukupally; Badikela Rama Krishna; T K Hima Bindu; Pranaya Pakir; T Ashwini; Kosika Sandeep; M Sesha Madhavi; and Dr. Shaik Harun Rasheed.

The application for the patent was published on Sept. 5, under issue no. 36/2025.

According to the abstract released by the Intellectual Property India: "The current investigation was pointed at developing and progressively validating novel, simple, robust, accurate, rapid, reproducible, and stability-indicating reverse phase- liquid chromatography method has been established for the assay of Ipilimumab in bulk and pharmaceutical dosage forms. ipilimumab was eluted from an Agilent C18 (50 x 2.6mm, 1.7 m) column at 15 C. Isocratic elution was performed using the mobile phase having mixture of Phosphate buffer : Methanol in the proportion of (10:90v/v). The Rate flow was maintained at 0.3 ml/min. and the maximum wavelength for column effluents was detected at 225nm using a PDA detector. The developed method has shown elution at 3 min. The whole analytical method validation was done satisfactorily as per ICH regulations. The recovery studies were performed at levels of 50%, 100% and 150%. The % recovery results were in the range of 99.91 to 100.81%, . The current method's regression co-efficient of 0.9989 showed that it was linear at concentrations between 20 and 120 g/ml. The % relative standard deviation results were seen to be 2%. ipilimumab was subjected to several stress conditions such as acid, neutral, base, peroxide, photolytic, and thermal for the stability testing. More recovery and minimal SD were observed. This approach was simple and affordable making it suitable for application in industries as a standard method of QC department. Key words: RP-UPLC, PDA detector, Ipilimumab and ICH Guidelines."

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