A Study of Method Development and Validation for Simultaneous Estimation of Pemetrexed and Cisplatin Using RP-HPLC

In September 2008, the FDA granted approval as a first-line treatment, in combination with cisplatin, against locally advanced and metastatic non-small cell lung cancer (NSCLC) in patients with non-squamous histology [5, 6]. cisplatin is a chemotherapy [7, 8] medication used to treat a number of can...

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Published inJournal of pharmaceutical sciences and research Vol. 13; no. 3; pp. 143 - 148
Main Author Rao, P T S R K Prasada
Format Journal Article
LanguageEnglish
Published Cuddalore Journal of Pharmaceutical Sciences and Research 01.03.2021
Subjects
Accuracy
Acids
Brain cancer
Chemotherapy
Chromatography
Empowerment
Lung cancer
Mesothelioma
Software
Testicular cancer
Mumbai India
India
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Summary:In September 2008, the FDA granted approval as a first-line treatment, in combination with cisplatin, against locally advanced and metastatic non-small cell lung cancer (NSCLC) in patients with non-squamous histology [5, 6]. cisplatin is a chemotherapy [7, 8] medication used to treat a number of cancers. [...]265 nm was selected for method validation. 2.6 Method Validation The analytical method was validated as per ICH Q2 (R1) guidelines for the parameters like system suitability, specificity, accuracy, precision, linearity, robustness, limit of detection (LOD), limit of quantification (LOQ), forced degradation and stability. 2.6.1 System Suitability System suitability parameters were measured to verify the system performance. Robustness study was performed by injecting standard solution into the HPLC system and altered chromatographic conditions such as flow rate (±0.2ml/min), organic content in the mobile phase (±10%). The separation factor, retention time and peak asymmetry were calculated by determining the effect of the modified parameters. 2.6.9 Stability Analytical solution was prepared and injecting into the HPLC system at periodic intervals of 0 hours to 24 hours at 6hour intervals depending on the instrument utilization and sequence of injection. 3.RESULTS AND DISCUSSION Optimization of Method and Standard solution concentration For the first chromatographic conditions selected for method is reversed-phase HPLC with Agilent eclipse XDB 150x4.6mm, 3.5p column with isocratic elution.
ISSN:0975-1459