Abstract
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredient of Sotorasib. Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Sotorasib. The chromatographic strategy utilized symmetry C18 column of dimensions 150x4.6 mm, 3.5 µ, using isocratic elution with a mobile phase of acetonitrile and 0.1% orthophosphoric acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 221 nm utilizing the PDA detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. Results: LOD and LOQ for the active ingredient were established with respect to test concentration. The calibration chart plotted was linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drug.
Highlights
Sotorasib, sold under the brand name Lumakras is an anti-cancer medication [1, 2] used to treat non-small-cell lung cancer (NSCLC) [3, 4]
Because the G12C KRAS mutation is relatively common in some cancer types, 14% of non-small-cell lung cancer adenocarcinoma [18] patients and 5% of colorectal cancer [19, 20] patients, and sotorasib is the first drug candidate to target this mutation, there have been high expectations for the drug
The Food and Drug Administration [21] has granted a fast track designation to sotorasib for the treatment of metastatic non-small-cell lung carcinoma with the G12C KRAS mutation
Summary
Sold under the brand name Lumakras is an anti-cancer medication [1, 2] used to treat non-small-cell lung cancer (NSCLC) [3, 4] It targets a specific mutation, G12C, in the protein KRAS [5, 6] , which is responsible for various forms of cancer [7]. Researchers evaluated the efficacy of sotorasib in a study of 124 participants with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with disease progression after receiving an immune checkpoint inhibitor [22, 23] and/or platinum-based chemotherapy [24, 25]. The aim of the study is to estimate the pharma ingredient Sotorasib by using RP-HPLC
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