Comparison of FT-NIR Transmission and HPLC to Assay Montelukast in Its Pharmaceutical Tablets

For several years, near-infrared spectroscopy (NIRS) has become an analytical technique of great interest for the pharmaceutical industry, particularly for the non-destructive analysis of dosage forms. The goal of this study is to show the capacity of this new technique to assay the active ingredient in low-dosage tablets. NIR spectroscopy is a rapid, non-destructive technique and does not need any sample preparation. A prediction model was built by using a partial least square regression fit method. The NIR assay was performed by transmission. The results obtained by NIR spectroscopy were compared with the conventional HPLC method for Montelukast tablets produced by Sigma pharmaceutical corp. The study showed that Montelukast tablets can be individually analyzed by NIR with high accuracy. It was shown that the variability of this new tech- nique is less important than that of the conventional method which is the HPLC with UV detection.

Evaluation of the Ability to Apply Near-Infrared Spectroscopy on Direct Assay of Acyclovir in Tablets

This paper aimed at developing a simple and fast approach using chemometrics processing for direct assay of acyclovir in tablets by NIR （near infrared） spectroscopy in diffuse reflectance mode. In making trials with 5 different tablet matrices, the experimental results showed that regardless the matrix variation, it was always possible to construct a quantitative model with suitable linear range, accuracy and precision for direct assay of acyclovir in tablet from NIR spectra. Therefore, the approach used in this study was suitable for on-site fast assay of APIs in tablets during manufacturing process or in post-marketing surveillance of drug quality.

Determination of Ketoconazole in Pharmaceutical Formulations

Ketoconazole has been widely used as an antifungal drug ketoconazole shampoo. The aim of this research was to study and to that is formulated as tablets, cream and over-the-counter standardize an UV （ultraviolet spectrophotometric） method, potentiometry and a HPLC （high performance liquid chromatographic） method for the determination ofketoconazole in commercially available tablets. These three methods were compared and discussed with respect to their sensitivity, selectivity and ready-applicability in routine analytical work. Absorption spectra and spectrophotometric determinations were carried out on the UV spectrophotometer. Investigated concentrations that ranged from 0.003 mg·dm^-3 to 0.02 mg·dm^-3. The absorbance was measured at 224 nm. In potentiometric titrations, glass and saturated （KCI） calomel electrodes were used to determine the end point of the titration. HPLC analyses of ketoconazole were carried in the presence ofeconazole as internal standard. It was concluded that the described methods are simple, fast and reliable for the identification of ketoconazole in pharmaceutical preparations. The preparation of the samples was easy, the excipients did not interfere with the active substance in the methods, so they can be used in routine quality control analysis.

Improvement in the dissolution rate and tableting properties of cefuroxime axetil by melt-granulated dispersion and surface adsorption

A combination of melt-granulated dispersion and surface adsorption techniques was used to enhance the dissolution and tableting properties of cefuroxime axetil(CA).Gelucire 50/13 was used as the melt-dispersion carrier and Sylysia 350 was used to adsorb the melt dispersion.Solubility studies showed an 8-fold increase in solubility at a ratio of 1:1.5 for CA:Gelucire 50/13.The minimum quantity of Sylysia 350 required to achieve the desired flowability and compressibility was 0.5 parts of Sylysia 350 per unit of Gelucire 50/13.Phase solubility studies showed negative ΔG_(tr)^(0) values for Gelucire 50/13 at various concentrations(2-10%,vv/v),indicating the spontaneous nature of solubilization.FT-IR and DSC spectra exhibited drug-excipient compatibility.Molecular modeling by a computational method employing energy minimization revealed entrapment of CA in Gelucire 50/13.The total potential energy of CA(70.562 keal/mol)was reduced to 33.578 keal/mol after solid dispersion with Gelucire 50/13.P-XRD studies indicated that the presence of Sylysia 350 is less likely to promote the reversion of the amorphous CA to a crystalline state.In vitro dissolution studies demonstrated an improved dissolution rate,and drug release at 15 min(Q_(15min))exhibited a 15-fold improvement.The rapidly dissolving CA tablets showed improved dissolution with improved tableting properties.