Stability Indicating Method Development and Validation for the Simultaneous Estimation of Dutasteride and Latanoprost in a Synthetic Mixture Using RP-HPLC Method

Abstract

This review article discusses the development and validation of a stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of Dutasteride and Latanoprost in a synthetic mixture. The main objective of such methods is to ensure accurate, precise, and specific quantification of active pharmaceutical ingredients (APIs) even in the presence of degradation products. Stability-indicating methods are critical for establishing the stability profile of drugs and ensuring quality control in accordance with ICH guidelines. The review focuses on various chromatographic parameters, validation criteria, and forced degradation studies, emphasizing their importance in developing robust, reproducible, and regulatory-compliant analytical procedures.

Introduction

The study focuses on developing and validating a stability-indicating RP-HPLC method for the simultaneous estimation of Dutasteride (used for benign prostatic hyperplasia) and Latanoprost (used for glaucoma) in synthetic mixtures. Due to differences in polarity, stability, and UV absorption, simultaneous analysis presents challenges, necessitating a method that meets ICH Q2(R1) guidelines.

A C18 column and optimized mobile phase (methanol, acetonitrile, and buffer) are used for separation, while forced degradation studies under acidic, alkaline, oxidative, photolytic, and thermal conditions ensure method specificity. The method is validated for specificity, linearity, accuracy, precision, LOD, LOQ, robustness, and system suitability, with high correlation coefficients, low %RSD, and satisfactory recovery results.

Results show well-resolved, symmetrical peaks for both drugs (retention times ~4.2 min for Dutasteride and ~6.1 min for Latanoprost), confirming the method is reliable, precise, accurate, and truly stability-indicating, capable of distinguishing drugs from their degradation products.

Conclusion

The developed RP-HPLC method for simultaneous estimation of Dutasteride and Latanoprost is precise, accurate, specific, and robust. It meets the requirements of a stability-indicating method as per ICH Q2(R1) guidelines. The method can be successfully applied for routine quality control of combined formulations, ensuring consistency and compliance with pharmaceutical standards.

References

[1] ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, 2005. [2] Snyder LR, Kirkland JJ, Dolan JW. Introduction to Modern Liquid Chromatography, 3rd Edition, Wiley, 2010. [3] Dong MW. Modern HPLC for Practicing Scientists, Wiley, 2006. [4] Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability-indicating studies of drugs—A review. J Pharm Anal. 2014;4(3):159–165. [5] Bakshi M, Singh S. Development of validated stability-indicating assay methods—Critical review. J Pharm Biomed Anal. 2002;28(6):1011–1040.

Copyright

Copyright © 2025 Riddhi Trivedi, Vandit Patel, Munshi Mahammed Tanzil M, Deepa R. Patel. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.