Stability Indicating RP HPLC Method Development and Validation of Everolimus in Bulk and Pharmaceutical Dosage Form
by Rushikesh Mulay | Rishikesh Bachhav "Stability Indicating RP-HPLC Method Development and Validation of Everolimus in Bulk and Pharmaceutical Dosage Form"
Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021,
Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46341/stability-indicating-rphplc-method-development-and-validation-of-everolimus-in-bulk-and-pharmaceutical-dosage-form/rushikesh-mulay
Everolimus is semisynthetic derivative of sirolimus, which is isolated from Streptomyces hygroscopicus. A novel reversed phase high performnce liquid chromatography HPLC method for determination of the everolimus in the presence of degradation product or pharmaceutical excipients. Seperation was carried out using Cosmosil C18 250mm x 4. 6ID , column having particle size 5 micron using acetonitrile and methanol mixture, and pH adjusted to 3, a flow rate of 1. 0 mL min, and ultraviolet detection at 285nm. A retention time nearly 3. 806 min was observed. The calibration curve for everolimus was linear from range of 5 25 µg mL with limit of detection and limit of quantitation of 0. 0817 and 0. 2478 µg mL, respectively. Analytical validation parameters such as selectivity, specificity, linearity, accuracy and precision were evaluated and relative standard deviation value for all the key parameters were less than 2. 0 . The stability indicating method was developed by exposing the drug to stress conditions of acid and base hydrolysis, oxidation, photodegradation, and thermal degradation the obtained degraded products were successfully seperated from the APIs. This method was validated in acceptance with ICH guidelines and results within the acceptance criteria.
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I hate being ignored by someone that I want attention from, I can count on my hand the number of people I actually want attention from but when one of those people ignore me it really fucks with my head kinda makes me numb to the rest of the world until I get over them but as soon as they hit me up to hangout or whatever I'm right back where I was until they ignore me again it may seem like nothing to most people but I'm a person of stability I need stable things in my life
