A Novel Derivatization Ultraviolet Spectrophotometric Method for the Determination of Amlodipine Besylate Using Benzoyl Chloride

The present research work aims to develop a novel ultraviolet UV spectrophotometric method for the determination of Amlodipine Besylate using Benzoyl Chloride as a derivatizing agent, which is simple, rapid, sensitive, selective, and accurate method for the spectrophotometric determination of Amlodipine Besylate in powder form.  Synthesis is based upon the Schotten Baumann Reaction. In this method, derivatization of aliphatic amine group of Amlodipine Besylate carried out with benzoyl chloride and aqueous sodium hydroxide (NaOH).The λmax was found to be 237 and 226nm for assay of Amlodipine Besylate and synthesised product respectively. The linearity was found in concentration range of 1-10 μg/ml. The correlation coefficient (r2)was found 0.9985. The regression equation, intercept (a) and slope (b) was found as Y=0.0762x - 0.0077, 0.0077 and 0.0762 respectively. Method was developed and validated as per ICH guidelines for linearity, accuracy, precision, LOD, LOQ, interday and intraday. The LOD and LOQ for estimation of Amlodipine besylate were found as 0.2367, 0.7178 respectively. Recovery of Amlodipine besylate was found to be 93.30%.The proposed method is found to be simple, rapid, selective and highly sensitive than most of the Spectrophotometric methods available in literature. Keywords: Derivatization, Ultraviolet spectrophotometry, Amlodipine besylate, Validation, Synthesis

Accurate prostate cancer detection based on enrichment and characterization of prostate cancer specific circulating tumor cells

Abstract Background The low specificity of serum PSA resulting in the inability to effectively differentiate prostate cancer from benign prostate conditions is a persistent clinical challenge. The low sensitivity of serum PSA results in false negatives and can miss high‐grade prostate cancers. We describe a non‐invasive test for detection of prostate cancer based on functional enrichment of prostate adenocarcinoma associated circulating tumor cells (PrAD‐CTCs) from blood samples followed by their identification by immunostaining for pan‐cytokeratins (PanCK), prostate specific membrane antigen (PSMA), alpha methyl‐acyl coenzyme‐A racemase (AMACR), epithelial cell adhesion molecule (EpCAM), and common leucocyte antigen (CD45). Methods Analytical validation studies were performed to establish the performance characteristics of the test using VCaP prostate cancer cells spiked into healthy donor blood (HDB). The clinical performance characteristics of the test were evaluated in a case–control study with 160 known prostate cancer cases and 800 healthy males, followed by a prospective clinical study of 210 suspected cases of prostate cancer. Results Analytical validation established analyte stability as well as acceptable performance characteristics. The test showed 100% specificity and 100% sensitivity to differentiate prostate cancer cases from healthy individuals in the case control study and 91.2% sensitivity and 100% specificity to differentiate prostate cancers from benign prostate conditions in the prospective clinical study. Conclusions The test accurately detects PrAD‐CTCs with high sensitivity and specificity irrespective of stage, serum PSA or Gleason score, which translates into low risks of false negatives or overdiagnosis. The high accuracy of the test could offer advantages over PSA based prostate cancer detection