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. 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, URL: https://www.ijtsrd.com/papers/ijtsrd46341.pdf 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
International Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 5 Issue 6, September-October 2021 Available Online: www. ijtsrd. com e-ISSN: 2456 – 6470
@ IJTSRD | Unique Paper ID – IJTSRD46341 | Volume – 5 | Issue – 6 | Sep-Oct 2021
Page 199
Stability Indicating RP-HPLC Method Development and Validation
of Everolimus in Bulk and Pharmaceutical Dosage Form
Rushikesh Mulay
1
, Rishikesh Bachhav
2
1Department of Pharmaceutical Quality Assurance, R. G Sapkal College of Pharmacy, Nashik, Maharashtra, India
2Department of Pharmacology, R. G Sapkal College of Pharmacy, Nashik, Maharashtra, India
ABSTRACT
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 & 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.
KEYWORDS: Everolimus, reversed-phase high performance liquid
chromatography, stablit