1Ph.D. Research Scholar, Department of Chemistry, Sinhgad Technical Education Society's Smt. Kashibai Navale College of Pharmacy Kondhva, Savitribai Phule Pune University, Pune, Maharashtra, India.
2Principal and Professor, Department of Chemistry, Sinhgad Technical Education Society's Smt. Kashibai Navale College of Pharmacy Kondhva, Savitribai Phule Pune University, Pune, Maharashtra, India.
3Ph.D Research Scholar, Department of Chemistry, Sinhgad Technical Education Society's Smt. Kashibai Navale College of Pharmacy Kondhva, Savitribai Phule Pune University, Pune, Maharashtra, India.
Corresponding Author: Mr. Pravin Sake, Email: Pravinsake7853@gmail.com
Background: Niraparib is selective poly (ADP-ribose) polymerase (PARP) inhibitor employed preliminary to mitigate ovarian, fallopian tube, or peritoneal cancer. Accurate and reliable analytical strategy is pivotal in quality control of niraparib in pharmaceuticals. Objective of current investigation is to develop as well as validate straightforward, rapid, precise, robust Reversed-phase high-performance liquid chromatography (RP-HPLC) strategy for quantitative determination of niraparib, with stability-indicating capability, in compliance with International Council for Harmonisation (ICH) guidelines.
Method: Chromatographic separation was accomplished employing Agilent Zorbax Bonus-RP column (4.6 mm × 250 mm, 5 µm particle size). Mobile phase consisted of 0.1% trifluoroacetic acid (TFA) in water and acetonitrile in a 75:25 v/v ratio, delivered in isocratic mode at flow rate of 1.0 mL/min. Detection wavelength was set at 240 nm, as well as injection volume was optimized at 20 µL. Method was validated for specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), along with robustness.
Result: Niraparib eluted with good peak symmetry and resolution with retention duration of 5.18 minutes. With R² > 0.999, method revealed linearity in concentration range of 40–60 µg/mL. Results explored that LOD was 1.42 µg/mL and LOQ was 4.30 µg/mL. With Relative standard deviation (RSD) of less than 2%, intra- and inter-day precision results were within appropriate limits, demonstrating great precision. Additionally, approach exhibited outstanding accuracy and robustness under varied conditions.
Conclusion: Developed RP-HPLC strategy was straightforward, accurate, precise, sensitive, as well as reliable. It is apt for regular stability testing and quality control analysis of niraparib in pharmaceuticals and bulk drugs. Its potential to suggest stability guarantees that it may be availed to monitor drug stability under variety of stress conditions and identify degradation products.
Keywords: Niraparib, RP-HPLC, method development, validation, forced degradation study, stability-indicating method.
How to cite this article: Sake P, Ghante M, Shegar S. Development and Validation of a Stability Indicating RP-HPLC method for Determination of Niraparib in Bulk Drug and its Pharmaceutical Dosage Form. Int J Drug Deliv Technol. 2026;16(11s): 358-366. DOI: 10.25258/ijddt.16.11s.34
Source of support: Nil.
Conflict of interest: None