Development and Validation of a Novel RP-HPLC Method for the Simultaneous Estimation of Antineoplastic Agents in Pharmaceutical Dosage Forms

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Thunga Anitha; S. Lakshmi Naga Aparna; U. Mohan Kumar; Meruva Jyothi

Development and Validation of a Novel RP-HPLC Method for the Simultaneous Estimation of Antineoplastic Agents in Pharmaceutical Dosage Forms

Authors: Thunga Anitha, S. Lakshmi Naga Aparna, U. Mohan Kumar, Meruva Jyothi

Unique Paper ID: 177362
Volume: 11
Issue: 12
PageNo: 1913-1917

Keywords: Method development Validation ICH guidelines Pharmaceutical analysis Quality control

Abstract:
High-Performance Liquid Chromatography (HPLC) is a vital technique for the qualitative and quantitative analysis of pharmaceutical substances. The present study describes the development and validation of a novel Reverse-Phase HPLC (RP-HPLC) method for the simultaneous estimation of selected antineoplastic agents. Chromatographic separation was achieved using a Kromosil C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase composed of Methanol and Phosphate buffer (pH 4.5) mixed in a 30:70 v/v ratio. The mobile phase was delivered at a constant flow rate of 1.0 mL/min and detection was carried out at 254 nm using a UV detector. The method exhibited excellent linearity over a wide concentration range, with correlation coefficients (r²) greater than 0.999 for both analytes. Validation was performed according to ICH guidelines, evaluating parameters such as specificity, accuracy, precision, linearity, limit of detection (LOD), limit of quantitation (LOQ), and robustness. The percentage recoveries were within the range of 98–102%, and precision studies showed %RSD values below 2%, confirming the method’s accuracy and reproducibility. LOD and LOQ values were satisfactory, indicating the sensitivity of the method. Robustness testing confirmed that minor variations in method parameters did not significantly affect system performance. The developed RP-HPLC method is thus simple, precise, accurate, and robust, and can be effectively applied for routine quality control and stability assessment of antineoplastic agents in pharmaceutical dosage forms.

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Cite This Article

ISSN: 2349-6002
Volume: 11
Issue: 12
PageNo: 1913-1917

Development and Validation of a Novel RP-HPLC Method for the Simultaneous Estimation of Antineoplastic Agents in Pharmaceutical Dosage Forms

Available:https://ijirt.org/article?manuscript=177362

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Journal no 47859

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