Conclusion: Results of all validation parameters were within the limits as per ICH guidelines. Keywords: HPLC, Validation, Method Development, Artemether, Accuracy, Ptrecission.M. LaxmiSomsubhra GhoshB. V. V. RavikumarInternational Journal of Pharmacy and Pharmaceutical Sciences...
The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness. 展开 关键词: Development degradation guaifenesin impurity HPLC stability-indicating validation ...
14. Jain DK, Patel P, Khan SA, Jain N, Development and validation of RP-HPLC method for simultaneous estimation of Atenolol and Lercanidipine ... PV Deore,AA Shirkhedkar,SJ Surana - 《Acta Chromatographica》 被引量: 9发表: 2008年 Simultaneous Spectrophotometric Estimation of Atenolol and Lerc...
The method was validated as per the ICH guidelines. The detection limit (LOD) was about 0.05 g/ml and quantitation limit (LOQ) was about 0.125 g/ml for (S)-isomer and Tenofovir disoproxil fumarate. The relative standard deviation was found to be 0.78 % for (S)-isomer in Tenofovir ...
The method was validated for all validation parameters as per ICH guidelines. The linearity range for capecitabine was 4-50µg/ml, with r2value of 0.9991. The % RSD for intra and interday precision was < 2%. The method has been validated in the assay of tablet dosage forms. ...
as per ISO 17025 guidelines,mandatory requirment for registration of any pharmaceutical product or pesticide formulation.The main objective is to demonstrate that the procedure is suitable for its intended purpose.the method validation studies for the developed methods for various parametersas per protocol...
Calibration curve showed linearity between absorbance and concentration as per line equation y=0.0347x-0.0071 with an R2 value of 0.9974. Validation was performed as ICH guidelines for linearity, accuracy and precision. The assay results were found to be in good agreement with label claim. 展开 ...
2.5. Method validation The method was validated in accordance with ICH guidelines Q2 (R1) for evaluation of various parameters that include linearity, precision, accuracy, limit of detection, limit of quantitation, specificity, and robustness [41]. Linear relationship between peak area and concentratio...
Analytical methods used in testing pharmaceutical stability samples need to be validated to the current standards. Often the same methods are employed for release and stability testing which facilitates method validation and allows for the use of initial
Per the FDA Guidance on Bioanalytical Method Validation (May, 2001), Accuracy of an analytical method describes the closeness of mean test results obtained by the method to the true value (concentration) of the analyte. This is sometimes referred to as Trueness or Bias. 2. Advanced Validation ...