1Research Scholar, Bhagwant University, Ajmer, Rajasthan, India. Email: bhawanimewada@gmail.com
2Bhagwant University, Ajmer, Rajasthan, India
A simple, rapid, cost-effective, and stability-indicating reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Tazarotene (TAZA) and Halobetasol propionate (HALO) in combined cream formulation. Chromatographic separation was achieved using a C18 column with an optimized mobile phase at a flow rate of 1.0 mL/min and detection at 254 nm. The method exhibited excellent linearity over the concentration range of 2–10 µg/mL for HALO and 1–5 µg/mL for TAZA, with correlation coefficients (r²) of 0.9994 and 0.999, respectively. The method was validated as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for parameters including linearity, accuracy, precision, robustness, specificity, limit of detection (LOD), and limit of quantitation (LOQ). Recovery studies showed results within 98–102%, and %RSD values for precision were less than 2%, indicating high reproducibility. Forced degradation studies under acidic, alkaline, oxidative, and thermal conditions demonstrated significant degradation without interference from degradation products, confirming the stability-indicating nature of the method. Assay results of marketed cream formulation were within acceptable limits. Hence, the developed RP-HPLC method is suitable for routine quality control and stability studies of combined TAZA and HALO pharmaceutical formulations.
Keywords: Tazarotene; Halobetasol propionate; RP-HPLC; Stability-indicating method; Method validation; Forced degradation; Cream formulation; ICH guidelines; Linearity; Precision.
How to cite this article: Mewada BS, Das S. Simple Cost Effective Stability Indicating Method Development of Tazarotene (TAZA) and Halobetasol (HALO) Using RP-HPLC. Int J Drug Deliv Technol. 2026;16(10s): 642-647; DOI: 10.25258/ijddt.16.10s.77
Source of support: Nil.
Conflict of interest: None