UV Method of Development and Validation of Olaparib

Year : 2024 | Volume : 15 | Issue : 02 | Page : 20 27
    By

    Arati Laxman Shinde,

  • Nikita Harekrishna Gurav,

  1. Assistant Professor, Department of Pharmaceutics, Dr. Shivajirao Kadam College of Pharmacy, Maharashtra, India
  2. Assistant Professor, Department of Pharmaceutics, Dr. Shivajirao Kadam College of Pharmacy, Maharashtra, India

Abstract

An analytical method must be developed and validated in the discovery, development, and production of pharmaceuticals 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 ultraviolet spectrophotometric approach was designed and validated using various characteristics, including linearity. Precision, reproducibility, accuracy, robustness, ruggedness, limit of detection, and limit of quantification are among the measuring criteria. The present study devised an accessible, economical, precise, and accurate ultraviolet spectrophotometric approach for assessing Olaparib in bulk and pharmaceutical formulation. The International Conference on Harmonization recommendations were followed in the evaluation of the method validation parameters. It was scanned in the range of 200–400 nm and ultraviolet spectrophotometric detection was carried out at absorption maxima (λmax) at 276 nm using methanol as a solvent. In the concentration range of 0.5–6 μg/ml, the techniques were linear (r2 =0.999). The precision is reported as 1.6% relative standard deviation. Accuracy, precision, robustness, and ruggedness, as well as specificity investigations, were all used to validate the methods. The Olaparib detector response was linear over the prescribed concentration range of 0.5–6 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 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 ]

How to cite this article:
Arati Laxman Shinde, Nikita Harekrishna Gurav. UV Method of Development and Validation of Olaparib. Research & Reviews: A Journal of Pharmaceutical Science. 2024; 15(02):20-27.
How to cite this URL:
Arati Laxman Shinde, Nikita Harekrishna Gurav. UV Method of Development and Validation of Olaparib. Research & Reviews: A Journal of Pharmaceutical Science. 2024; 15(02):20-27. Available from: https://journals.stmjournals.com/rrjops/article=2024/view=156766


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Regular Issue Subscription Original Research
Volume 15
Issue 02
Received 16/04/2024
Accepted 27/05/2024
Published 18/07/2024
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