International Journal of Drug Delivery Technology
Volume 16, Issue 4s

Development and Validation of an RP-HPLC Method for Simultaneous Estimation of Rosuvastatin and Ezetimibe in Solid Dosage Form Using Analytical Quality by Design (AQbD) Approach

Sanjeev Kumar1, Govindarao Yedlapalli2, Darla Swarna Latha3, Venu Kumari Guntupalli4, Ganjarapalli Yamini5, Rishiram Tripathi6, Gauri7, Rajesh Guntupalli8*

1Assistant Professor, Department of Chemistry, Government College, Rajakhera, Dholpur, Rajasthan, India 328025
2Professor, Malineni Perumallu Pharmacy College, Pulladigunta, Guntur, A.P-522017
3Assistant Professor, Malineni Perumallu Pharmacy College, Pulladigunta, Guntur, A.P-522017
4Associate Professor, Malineni Perumallu Pharmacy College, Pulladigunta, Guntur, A.P-522017
5Assistant Professor, Malineni Perumallu Pharmacy College, Pulladigunta, Guntur, A.P-522017
6Research Scholar, Sanskriti University, Mathura 281401
7Assistant Professor, University School of Pharmaceutical Sciences, Rayat Bahra University, Mohali, Punjab 140104
8*Associate Professor, Malineni Perumallu Pharmacy College, Pulladigunta, Guntur, A.P-522017

(Corresponding Author)

ABSTRACT

Background: Hyperlipidemia is a major risk factor for cardiovascular disease, and the combination therapy of Rosuvastatin and Ezetimibe provides synergistic lipid-lowering benefits. Reliable analytical methods are required to ensure quality and stability of fixed-dose formulations.

Objective: The present study aimed to develop and validate a simple, precise, and robust RP-HPLC method for simultaneous estimation of Rosuvastatin and Ezetimibe in solid dosage forms using an Analytical Quality by Design (AQbD) approach.

Methods: Preliminary trials were performed to evaluate the effect of mobile phase composition, flow rate, and pH on chromatographic behavior. Critical method parameters were optimized using a Box–Behnken design, and the design space was established through ANOVA, 3D response surface plots, and overlay contour plots. The optimized chromatographic conditions consisted of acetonitrile:water (70:30, v/v) as mobile phase, a flow rate of 1.0 mL/min, and UV detection at 234 nm. Method validation was conducted according to ICH Q2(R1) guidelines.

Results: The method exhibited excellent linearity over the range of 5–20 µg/mL with correlation coefficients above 0.999 for both drugs. Accuracy studies showed recoveries within 98–102%, while precision results demonstrated %RSD values less than 2.0% for repeatability and intermediate precision. Robustness studies confirmed the resilience of the method to minor variations, and LOD/LOQ values of 0.15/0.45 µg/mL (Ezetimibe) and 0.18/0.55 µg/mL (Rosuvastatin) confirmed high sensitivity. Forced degradation studies established the method as stability-indicating.

Conclusion: The validated AQbD-based RP-HPLC method is reliable, accurate, and robust for routine quality control and stability testing of Rosuvastatin–Ezetimibe solid dosage formulations, fulfilling regulatory and industry requirements.

Keywords: Rosuvastatin, Ezetimibe, RP-HPLC, Analytical Quality by Design (AQbD), Method validation, Hyperlipidemia.

How to cite this article: Kumar S, Yedlapalli G, Latha DS, Guntupalli VK, Yamini G, Tripathi R, Gauri, Guntupalli R, Development and Validation of an RP-HPLC Method for Simultaneous Estimation of Rosuvastatin and Ezetimibe in Solid Dosage Form Using Analytical Quality by Design (AQbD) Approach. Int J Drug Deliv Technol. 2026;16(4s): 831-839; DOI: 10.25258/ijddt.16.4s.96

Source of support: Nil

Conflict of interest: None