Objective: A simple, accurate and precise reversed phase High Performance Liquid Chromatography (HPLC) method for rapid and simultaneous quantification of Daunorubicin and Cytarabine in rat plasma was developed and validated. Methods: The chromatographic separation was achieved on Symmetry C18 (150x4.6mm, 3.5µ) column. The Buffer was Hexane Sulphonic acid at pH 2.5 adjusted with Ortho Phosphoric acid (OPA) and the mobile phase was a mixture of buffer and Acetonitrile in the ratio of 65:35 v/v, flow rate 1.0ml/min and UV detection was carried out at 236nm. Results: The proposed method shows a good linearity in the concentration range of 1-15µg/ml for Daunorubicin and 2.27-34.05µg/ml for Cytarabine under optimised conditions. Precision and recovery study results are in range 98-102%. In the entire robustness conditions %RSD is below 2.0%. Degradation has very less effect in stress condition and solutions remained stable up to 24 hrs. This method is validated for different parameters like selectivity, sensitivity, matrix effect, linearity, precision and accuracy, recovery, reinjection, reproducibility, limit of detection (LOD), limit of quantification (LOQ) and stability were determined according to the ICH Q2B guidelines. All the parameters of validation were found to be in acceptance with ICH guidelines. Conclusion: The results obtained demonstrate that proposed strategy can be effortlessly and advantageously applied for routine examination of daunorubicin and cytarabine in rat plasma.

Solid Phase Peptide Synthesis, based on FMOC-chemistry is currently an extremely preferred approach in chemical synthesis of Peptides though it has various limitations attributed by high raw material costs, solvents and waste volumes1. Downstream processing steps of peptides involves coupling of several amino acids, each amino acid have contained considerable proportions of impurities. High process impurities and solvent load intensifies the complexity of conventional purification approaches. In our study, we employed raw material purification prior to peptide synthesis by which we aimed to bring down the residual impurity level of peptide under the study and reduction of waste load on HPLC which lead to higher peptide purity. A comparison of crude peptide and the peptide synthesized with purified Amino acids showed >15% increase in purity.

Process validation is the demonstrating documented proof which gives high intensity of affirmation that a specific process constantly produces a product meeting its proposed specifications and quality characteristic. According to GMP validation studies are important part of GMP these are needed to be done as per predefined protocols. The validation study gives the accuracy, sensitivity, specificity and reproducibility of the test methods hired by the firms, shall be established and documented. Thus the validation is an important part of the quality assurance.

The encapsulation of drugs inside polymeric nanoparticles/microparticles is a strategy currently employed in the search for new and more effective therapies. The use of biocompatible and biodegradable polymers gives several advantages to these formulations. Protection of the active principals against the action of environmental and physiological agents, the reduced number of doses and a subsequent decrease in drug-related adverse effects, and increased bioavailability are some of these advantages. This review outlines the ionotropic gelation method for the preparation of chitosan-based nanoparticulate drug delivery systems published over the past decade. From a literature survey, it was found that research activities on chitosan-based micro/nanoparticles having various drugs for various therapeutic applications have increased at the rapid rate. Hence ionotropic gelation method can use to arrange these chitosan nanoparticles as it is incredibly simple and having many advantages then other methods.

In the simultaneous estimation of Diazepam and Propranolol HCl by RP-HPLC method development, the optimized chromatographic condition was selected by taking a mobile phase combination of mixed phosphate buffer (0.02M potassium dihydrogen orthophosphate and 0.003M dipotassium orthophosphate pH adjusted to 3.0 with ortho-phosphoric acid) and acetonitrile in a ratio of 40:60 v/v. BDS Hypersil (250x4.6 I.D, 5µ) was selected as the column. The flow rate was selected as 1.0mL/ min. The UV- detection wavelength was taken as 222nm, by using this detection was carried out. The method development was carried out by external standard method. By the use of the above chromatographic conditions, the peaks are found to be symmetrical, with good resolution. The retention times of Diazepam and Propranolol HCl was found to be 2.031 and 5.597 min. The run time was found to be short and the peaks are eluting with good resolution. The linearity studies of Diazepan and Propranolol HCl were found to be in the range of 2-12µg/mL and 16-96µg/mL respectively. The slope, intercept and correlation coefficient of Diazepam and Propranolol HCl were 26.01, 11.87, 0.999 and 4.328, 11.54, 0.999 respectively. The linearity data suggests that the linearity was within the Beer Lamberts limit.