International Journal of Pharmaceutical Chemistry and Analysis

123-129

Authors: A. V. Ganokar*,S U. Bhoyar,N S. Raut,K R. Gupta

The challenges in the field of chromatographic separation mainly fast and efficient separation for variety of samples has led to the changes in particle size, improvement in packing material design, development of synthetic method has provided the possibility of fabricating silica nanoparticle with different sizes in nanometer ranges. In present review, we have tried to show the journey of silica particle over the years and changes in the size, surface, internal pore size and packings. Their applications especially the mesoporous nanoparticles have also been mentioned.

133-140

Authors: Dhara R. Patel*

The present work describes a simple, accurate and precise Stability indicating RP-HPLC method for the estimation of Capecitabine (CPT) in bulk and pharmaceutical formulation. The Mobile phase used was Acetonitrile: Water (60: 40v/v) with 1ml/min. flow rate and 240nm was used as a wavelength maximum. The C18 HS (250 X 4.6) mm, 5 µm column was used as a stationary phase. The method was validated as per the ICHQ2 Guidelines. The retention time of CPT was found to be 3.3 min. A linear response was observed in the range of 10-50 ?g/mL with a regression coefficient of 0.999. The LOD and LOQ were found to be 1.43?g/mL and 4.34?g/mL respectively. This method can be used for the determination of CPT in quality control of API and dosage form without interference of the excipients, impurities and degradation products and hence can be used as stability indicating assay method. CPT was subjected to degradation under different stress conditions recommended by ICH viz acid, alkali, photolytic, dry heat and oxidative condition. The samples so generated were used for degradation studies including degradation kinetic study using the developed method. The degradation pathway of CPT was found to be acid hydrolysis and temperature exceeding 100°c. The degradation kinetic study shows that the acid hydrolysis, alkaline hydrolysis and oxidative degradation of the CPT follow first order kinetic.

144-146

Authors: M P. Shinde*,Aishwarya Patil,A. P. Bendale,S. P. Narkhede,A G. Jadhav

Tenofovir alafenamide is a nucleic acid analogue that is used for treatment of HIV infection and Hepatitis B. As compared with the other prodrug of tenofovir, tenofovir alafenamide is having less side effects, it is Steady in plasma and then quickly changed over into tenofovir once inside cells. The main aim and objective of present study was to perform the stability indicating studies as defined under ICH Guideline Q1A R2) by using UV spectrophotometer. According to ICH guidelines, of temperature, time, photo degradation, acid/base are the factors which are responsible for formation degradation product of a drug. UV-Vis spectroscopy method was intiated to study and compute the amount of drug in the presence of degradation products. The method was developed by using water as diluents and ? max was 260nm. Linearity was established for in the range of 2-10 ?g/mL with regression coefficient of 0.9912. The drug was subjected to acid, alkali and neutral hydrolysis, oxidation degradation conditions. The limits of detection (LOD) and quantification (LOQ) were calculated and found to be 1.43 ?g/mL and 4.33?g/mL, respectively. The method was found to be simple, economic and less time consuming as compared to other analytical techniques.

151-155

Authors: Sruthi K,Prasanth S.S*,Kamarunnisa K,Drisya N.K,Ashyam K

A fourier transform infrared (FTIR) spectrometric method was developed for the rapid, direct determination of levosulpiride in different pharmaceutical products.1-3 The universal ATR spectra were recorded and used for this study. Multiple linear regression (MLR) where a restricted set of absorption band is used for calibration beer-lambert law was used for data processing. A recovery of 98.5% of levosulpiride from the tablet dosage form with a correlation coefficient of 0.996 was obtained. The aim of this study was to develop a FTIR spectrophotometric procedure for the analysis of levosulpiride in raw material and tablets. The linear regression equation for levosulpiride was calculated to be y=189.04+152.39*x where x and y are concentration and integrated peak area respectively. The method had excellent reproducibility for the standard of 50 mg, 49.5 ±1.02 mg (n =6). The recovery test is an experimental design to verify the relationship between the amount of substance added and the amount quantified by this assay. In this test the observed concentrations of pure levosulpiride in the powdered tablets were not significantly different from the stated concentrations by student's t test, p = 0.05% (100.04 ± 1.49%, n = 3) the method gave rise to linear data in the range 2-50. Mg with accuracy and precision in the range 0.77-3.2%. Therefore, this FTIR-spectrophotometric assay was accurate, and may be recommended for the simple quantification of levosulpiride.