Method Development, Validation and Estimation of Relative Response Factor for the Quantitation of Known Impurities in Mometasone Furoate Nasal Spray Dosage form by RP-HPLC with UV/PDA Detector

Mometasone furoate is a corticosteroid drug used in various pharmaceutical dosage forms, mainly nasal spray, nasal implant, inhalation powder, topical cream, lotion, ointment etc. for wide therapeutic applications. From literature survey, it was found that no any HPLC method was reported for the quantitation of four known toxic impurities of mometasone furoate. In the present work, an attempt was made to develop an accurate, precise and robust analytical method for the quantitation of these known toxic impurities in mometasone furoate API and its nasal spray dosage form by using a simple RP-HPLC technique with PDA detector. The known impurities of mometasone furoate are either not available easily or rather costly to purchase. Hence, we have determined the relative response factor of these known impurities for accurate quantitation. A mixture of octanesulfonic acid sodium salt and phosphate buffer at pH 3.0 was used as mobile phase A and pure acetonitrile as mobile phase B. Linear isocratic elution was set at 45:55 v/v ratio of mobile phases A and B, respectively, and 0.8 mL/min flow rate. Required resolution between the peaks of mometasone furoate and all the known and unknown impurities was achieved using Bakerbond C18, 250 × 4.6 mm, 5 μm column. The column was operated at 50°C with 254 nm as a UV/PDA detector wavelength. The developed method was validated as per ICH guidelines. The forced degradation study was carried out by using acid, alkali, thermal, photolytic and oxidative stress conditions for the evaluation of stability indicating nature of the method. The maximum degradation (12.4%) was observed in 0.1 N NaOH. The developed method has been found accurate, linear, precise, specific and robust and can be routinely used for the quantitation of four known toxic impurities in drug quality control laboratories.