Stability-indicating RP-HPLC method development and validation for simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and in tablet dosage form

Abstract

Abstract Background The stability-indicating chromatographic method was developed and validated for simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and in tablet dosage form. The RP-HPLC elution was carried out at 242.0 nm using column Oyster ODS3 (150 × 4.6 mm, 5 µm) isocratically, and a mobile phase containing 10 mM phosphate buffer with 1.1 g octane-1-sulfonic acid sodium salt having pH 2.5 (adjusted with 5% OPA) and acetonitrile, with a proportion of 500:500, v/v was pumped through the column maintained at ambient (about 25 °C) temperature with 1.0 mL/min flow rate. The proposed method was validated according to ICH Q2 (R1) guideline. Results Telmisartan and rosuvastatin were eluted at 2.553 min and 4.505 min, respectively. The method is linear from 99.9073 to 299.7218 µg/mL for telmisartan (R2 = 1.000) and 23.6841 – 71.0522 µg/mL for rosuvastatin (R2 = 0.999). The average recovery percentage was found 100.51, 99.76, and 99.14% for telmisartan and 99.68, 99.72, and 98.56% for rosuvastatin at three different levels. Results of method repeatability and intermediate precision were found within acceptable limits. Results of solution stability showed that mobile phase was stable for 2 days; standard and sample preparations are stable for 1 day at room temperature as well as in the refrigerator (2–8 °C). Also, forced degradation study results show that method is stability indicating as capable of distinguishing the active analytes peak from the degraded product. Conclusion The developed stability-indicating method is linear in studied concentration range as well as precise, accurate, specific, and robust. Hence, successfully this method can be used for routine analysis and stability study. Graphical abstract