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<p>A simple, economic, accurate, sensitive, specific and precise analytical technique for the estimation of Indacaterol and Mometasone by RP-HPLC was developed and validated. The chromatographic separation was carried out by using Thermo Scientific BDS Hypersil C18 (250 × 4.6 mm, 5 μ particle size) as a stationary phase and 2 % trifluoroacetic acid in water: methanol: acetonitrile (20:50:30 v/v/v) as a mobile phase. The flow rate of 1 ml/min was used with UV detection at 250 nm. The retention time of Indacaterol and Mometasone was 4.0 and 5.1 min, respectively. RP-HPLC method was developed with a linearity range of 2 – 12 μg/ml of Indacaterol and 2 – 12 μg/ml of Mometasone. The correlation coefficient r2 was found to be 0.999 for Indacaterol and 0.997 for Mometasone. Accuracy of the method was confirmed by recovery studies and the recoveries were found to be between 106% and 107%. The limit of Detection 0.437 g/ml was for Indacaterol and 0.746 μg/ml for Mometasone. The limit of Quantitation was 1.324 μg/ml for Indacaterol and 2.263 μg/ml for Mometasone. Precision, LOD, LOQ, specificity, robustness and ruggedness were performed as per ICH Q2(R1) guidelines and were within the acceptance criteria.</p>

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Method Development and Validation for Simultaneous Estimation of Indacaterol and Mometasone Using RP-HPLC

  • 期刊论文

  • 发表日期：

    2025年1月1日

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  • A. S. Bansode,
  • S. S. Bagul,
  • S. S. Gaikwad,
  • S. S. Kukade,
  • N. A. Ghadagepatil

摘要

A simple, economic, accurate, sensitive, specific and precise analytical technique for the estimation of Indacaterol and Mometasone by RP-HPLC was developed and validated. The chromatographic separation was carried out by using Thermo Scientific BDS Hypersil C18 (250 × 4.6 mm, 5 μ particle size) as a stationary phase and 2 % trifluoroacetic acid in water: methanol: acetonitrile (20:50:30 v/v/v) as a mobile phase. The flow rate of 1 ml/min was used with UV detection at 250 nm. The retention time of Indacaterol and Mometasone was 4.0 and 5.1 min, respectively. RP-HPLC method was developed with a linearity range of 2 – 12 μg/ml of Indacaterol and 2 – 12 μg/ml of Mometasone. The correlation coefficient r2 was found to be 0.999 for Indacaterol and 0.997 for Mometasone. Accuracy of the method was confirmed by recovery studies and the recoveries were found to be between 106% and 107%. The limit of Detection 0.437 g/ml was for Indacaterol and 0.746 μg/ml for Mometasone. The limit of Quantitation was 1.324 μg/ml for Indacaterol and 2.263 μg/ml for Mometasone. Precision, LOD, LOQ, specificity, robustness and ruggedness were performed as per ICH Q2(R1) guidelines and were within the acceptance criteria.