Simultaneous estimation of mometasone furoate and olopatadine hydrochloride by reversed‐phase high‐performance liquid chromatography

Abstract

The simultaneous determination of Mometasone furoate (MOM) and Olopatadine hydrochloride (OLO) in a combined dose has been developed and validated using a specific, precise, accurate, fast, reliable, and economical high‐performance liquid chromatography technique. Methanol:water:acetonitrile (20:25:55, v/v/v) was used as the mobile phase during the separation. The procedure was performed using a low‐pressure gradient elution on the reversed‐phase Phenomenex C18 column. At 238 nm, separated components were densitometrically measured. The flow rate was fixed at 1.0 mL/min with a continuous run up to 10 min, while the retention time was located near about 3.2 and 6.1 min for OLO and MOM, respectively. The method was validated for Linearity and range, precision, reproducibility, specificity, accuracy, limit of detection, limit of quantification, and robustness as per the International Council for Harmonization Q2(R1) guideline. MOM and OLO regression coefficients (r2) were found to be 0.9994 and 0.9997, over the range of 2.5–15 and 33.25–199.5 µg/mL, respectively. MOM and OLO percentage recoveries were measured to be 99.49 ± 0.14 and 99.98 ± 0.22, respectively. The method can be successfully applied for routine analysis of the quantitative determination of MOM and OLO in a combined dose.