Arati Laxman Shinde,
Nikita Harekrishna Gurav,
- Assistant Professor Department of Pharmaceutics, Dr. Shivajirao Kadam College of Pharmacy Maharashtra India
- Assistant Professor Department of Pharmaceutics, Dr. Shivajirao Kadam College of Pharmacy Maharashtra India
Abstract
In the discovery, development, and production of pharmaceuticals an analytical method must be developed and validated to ensure the identification, purity, potency, and performance of drug commodities, quality control laboratories use official test protocols that emerge from the processes. A simple UV spectrophotometric approach was designed and validated using various characteristics, including linearity. Precision, reproducibility, accuracy, robustness, ruggedness, limit of detection (LOD), and limit of quantification (LOQ) are among the measuring criteria. This study devised an accessible, economical, precise, and accurate UV spectrophotometric approach for assessing Olaparib (OLA) in bulk and pharmaceutical formulation. The International Conference on Harmonization (ICH) recommendations were followed in the evaluation of the method validation parameters. It was scanned in the range of 200- 400 nm and UV spectrophotometric detection was carried out at absorption maxima (λmax) at 276 nm using methanol as a solvent. In the concentration range of 0.5 to 6 μg/ml, the techniques were linear (r2 =0.999). The precision is reported as 1.6 percent relative standard deviation (R.S.D.). Accuracy, precision, robustness, and ruggedness, as well as specificity investigations, were all used to validate the methods. The Olaparib (OLA) detector response was linear over the prescribed concentration range of 0.5 to 6 μg/ml. The validity of the described procedure was investigated. The results were statistically examined, and the precision and accuracy were determined to be extremely high. The process was found to be straightforward, precise, and accurate, and it can be utilized for routine quality control of Olaparib (OLA) in bulk and solid dosage formulations. There is no interference from common excipients in the above approach.
Keywords: UV-Spectroscopy, Olaparib, method development, validation, methanol.
[This article belongs to Research & Reviews: A Journal of Pharmaceutical Science(rrjops)]
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Research & Reviews: A Journal of Pharmaceutical Science
| Volume | 15 |
| Issue | 02 |
| Received | April 16, 2024 |
| Accepted | May 27, 2024 |
| Published | July 18, 2024 |