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<p>Combination nasal spray products containing fluticasone furoate and oxymetazoline hydrochloride are commonly used to treat asthma, chronic pulmonary diseases, and perennial allergic rhinitis. However, testing for impurities in pharmaceutical products is a challenging task due to the similarity in properties between the impurities and the drugs. It is important to strictly maintain the product safety and quality to ensure the regulatory compliance. An attempt has been made to develop and validate a new simple, single-run RP-HPLC method for the simultaneous estimation of seven known and several unknown impurities from fluticasone furoate and oxymetazoline hydrochloride nasal spray products<b>.</b> The separation of multiple impurity peaks was achieved by using a 5&#xa0;µm, Inertsil ODS 3&#xa0;V, 250 × 4.6&#xa0;mm column. Dual-wavelength UV detector (220&#xa0;nm and 240&#xa0;nm) was used for the detection of oxymetazoline hydrochloride, fluticasone furoate and their impurities. The relative response factor was calculated for all the known impurities to make the method accurate, simple and economical. The developed method was validated following the guidelines outlined in the ICH Q2(R2). The forced degradation study results confirmed the stability-indicating nature of the method. The developed impurity profiling methodology will greatly help the quality control labs in maintaining the safety and efficacy of finished products and to comply with the regulatory requirements of various countries. Overall, the proposed method offers unparalleled precision, accuracy, sensitivity, and cost-effectiveness making it a valuable addition to the pharmaceutical industry.</p>

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Quantification of Seven Known and Several Unknown Impurities from Fluticasone Furoate and Oxymetazoline Hydrochloride Nasal Spray Product Using RP-HPLC UV Methodology

  • 期刊论文

  • 发表日期：

    2025年2月10日

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  • Shrikant V. Kulkarni,
  • Surbhi Lokhande,
  • Bhaskar D. Musmade,
  • Shrinivas G. Bhope,
  • Mitesh Nagar,
  • Sharad P. Panchgalle,
  • Vijaykumar S. More

摘要

Combination nasal spray products containing fluticasone furoate and oxymetazoline hydrochloride are commonly used to treat asthma, chronic pulmonary diseases, and perennial allergic rhinitis. However, testing for impurities in pharmaceutical products is a challenging task due to the similarity in properties between the impurities and the drugs. It is important to strictly maintain the product safety and quality to ensure the regulatory compliance. An attempt has been made to develop and validate a new simple, single-run RP-HPLC method for the simultaneous estimation of seven known and several unknown impurities from fluticasone furoate and oxymetazoline hydrochloride nasal spray products. The separation of multiple impurity peaks was achieved by using a 5 µm, Inertsil ODS 3 V, 250 × 4.6 mm column. Dual-wavelength UV detector (220 nm and 240 nm) was used for the detection of oxymetazoline hydrochloride, fluticasone furoate and their impurities. The relative response factor was calculated for all the known impurities to make the method accurate, simple and economical. The developed method was validated following the guidelines outlined in the ICH Q2(R2). The forced degradation study results confirmed the stability-indicating nature of the method. The developed impurity profiling methodology will greatly help the quality control labs in maintaining the safety and efficacy of finished products and to comply with the regulatory requirements of various countries. Overall, the proposed method offers unparalleled precision, accuracy, sensitivity, and cost-effectiveness making it a valuable addition to the pharmaceutical industry.