International Journal of Drug Delivery Technology
Volume 15, Issue 1

A Novel Stability Indicating Method Development and Validation for Simultaneous Estimation of Oxcarbazepine and Olanzapine by RP-HPLC in Pharmaceutical Dosage Form

Aparajita Neogi1, Chandan R S1*,Haritha Reddy Nagidi 2, Pavani Sunkishala3

1Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka-570015, India

2Department of Pharmaceutical analysis, Care college of Pharmacy, Oglapur, Warangal, Telangana, India

3PCI Pharma Services,23 Commerce Drive, Bedford, New Hampshire, 03110   United States

Received: 21st Nov, 2024; Revised: 5th Jan, 2025; Accepted: 15th Jan, 2025; Available Online: 25th Mar, 2025

ABSTRACT

A novel stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of Oxcarbazepine and Olanzapine in pharmaceutical dosage forms. The method utilized a Waters X-Terra RP-18 column with a mobile phase composition of acetonitrile and 0.1% triethylamine (30:70), pH adjusted to 2.5 using orthophosphoric acid. The flow rate was maintained at 1 mL/min, and detection was carried out at 272 nm. The method demonstrated excellent linearity for Oxcarbazepine (37.50–225.00 µg/mL, R² = 0.99989) and Olanzapine (5.00–30.00 µg/mL, R² = 0.99973), along with high precision and accuracy (%RSD < 1.0). Robustness was confirmed under varied conditions, and forced degradation studies validated the method's specificity, with no significant interference from degradants. The proposed method is reliable, reproducible, and suitable for routine analysis of Oxcarbazepine and Olanzapine in combined dosage forms.

Keywords; RP-HPLC, Oxcarbazepine, Olanzapine, Stability-indicating method, Method validation

How to cite this article: Aparajita Neogi, Chandan R S,Haritha Reddy Nagidi, Pavani Sunkishala. A Novel Stability Indicating Method Development and Validation for Simultaneous Estimation of oxcarbazepine and olanzapine by RP-HPLC in Pharmaceutical Dosage Form. International Journal of Drug Delivery Technology, 2025;15(1):216-21. doi: 10.25258/ijddt.15.1.30

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