Bhargavi S,
Paul Richard M,
B.A Vishwanath,
- Pharm D Student, Department of Pharmaceutical Analysis, Aditya Institute of Pharmacy Education and Research, Karnataka, India
- Professor Department of Pharmaceutical Analysis, Aditya Institute of Pharmacy Education and Research, Karnataka, India
- Chairman, Department of Pharmaceutical Analysis, Aditya Institute of Pharmacy Education and Research, Karnataka, India
Abstract
A new simple, precise, selective, and accurate, a new method development and validation using Rp-HPLC for the estimation of Aclidinium bromide and Formoterol Fumarate in its pure and pharmaceutical dosage form. Chromatogram was run through DIKMA Spursil, C18 segment (4.6×150mm, 5µ0). Mobile phases contain 0.1%OPA: Acetonitrile (30:70) with the use of the 0.1%OPA buffer, stream rate of 1ml/min and measured in 280nm. The run time were found to be 1.965 mins and 3.826mins and precision of Aclidinium and Formoterol was found to be 0.7, 0.2. The accuracy of Aclidinium and Formoterol were found to be 99.74 and 100.53. % recovery obtained in Aclidinium and Formoterol 99.74% and 100.53%.LOD, LOQ results were 3.03, 3.00and 10.02, 10.00.% of purity of Aclidinium and Formoterol was found to be 100.14 %and 99.92%. The method exhibits precision of 0.4 and 0.2 for Aclidinium and Formoterol, which shows that the method is repeatable when performed on different days as well. The acceptance threshold of intermediate precision is RSD should be not more than 2.0%. The range of 98.0% to 102.0% should be the percentage recovery, which is the accuracy limit. Validation of the suggested methodology indicates that Dolutegravir has good accuracy.
Keywords: Rp-HPLC, Aclidinium bromide, Formoterol fumarate, UV spectrophotometer, Validation, Development.
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Research & Reviews: A Journal of Pharmaceutical Science
| Volume | |
| Received | July 15, 2024 |
| Accepted | September 3, 2024 |
| Published | September 7, 2024 |