Analytical method development being a vital part of pre formulation-formulation research and development obviates the need to develop reliable, effective, eco friendly and cost effective methodologies for routine analysis of active pharmaceutical ingredients. UV spectroscopy is one of the earliest, yet of wide applications in drug analysis in different stages of formulations and quality control; despite the availabilities of sophisticated chromatographic techniques and other hyphenated techniques. Current research attempts to develop simple, sensitive, accurate, precise and economical UV spectrophotometric methods for the routine analysis of acyclovir in bulk and pharmaceutical dosage forms using two separate alkaline media, 0.1N NaOH (method A) and 0.1N KOH (method B) and validate them as per ICH guidelines. In both the methods maximum absorbance was observed at 264 nm. Beer's law was obeyed in the concentration of 2.5-40 µg / mL in method A and 2.5-30 µg / mL in method B with correlation coefficient of 0.999. The % recovery carried out by adding known amount of standard drug to pre-analyzed tablet solutions was 98.75 ± 0.52 % to 99.78 ± 0.69 % (method A) and 98.55 ± 0.31 % to 99.78 ± 0.22 % (method B). Intra and interday precision expressed in % RSD were 0.38 ± 0.01 and 0.27 ± 0.02 -0.44 ± 0.01 respectively and the percent purity was 99.85 ± 0.05 %. The methods were validated statistically as per ICH guidelines and the results obtained were within the acceptance criteria for the parameters relating to linearity, accuracy, precision.
The objective of the present study was to prepare and characterize the microcapsules for the controlled release of Stavudine using cellulose acetate butyrate (CAB), ethyl cellulose (EC), hydroxy propyl methyl cellulose phthalate (HPMCP). The microcapsules were prepared by solvent evaporation method using acetone and liquid paraffin as a drug dispersion and liquid manufacturing phase, respectively. The prepared microcapsules were characterized for particle size distribution (PSD), percent drug content, entrapment efficiency, Fourier Transform Infrared Spectroscopy (FTIR), differential scanning calorimetry (DSC), scanning electron microscopy (SEM) and in vitro dissolution studies. The prepared microcapsules were filled in hard gelatin capsules and kept for accelerated stability study as per ICH guidelines for about 3 months. The prepared microcapsules were spherical and free flowing. The entrapment efficiency was found to be 25-45%. The release of drug from the microcapsules was extended upto 12 hours and more. FTIR and DSC thermo graphs showed stable character of stavudine. Scanning electron microscopic study revealed that then microcapsules were spherical and porous in nature. The release kinetics study revealed that the prepared microcapsules were best fitted to the Higuchi model, first order and followed by Zero order and indicating that the drug release was diffusion controlled. The release was mainly influenced by the type of polymer and its viscosity. The DSC study revealed that there is no drug to polymer interaction and showed the stable character of the drug which was further confirmed by the assay of accelerated stability of microcapsules.
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