Assessment of diurnal variation in Ocimum sanctum Linn. by gas chromatographic fingerprint analysis coupled with chemometric methods

Vast intra-specific variations, especially diurnal, geographical and seasonal, have been reported in the chemical composition of essential oils of Ocimum species. The study was conducted to assess diurnal variation in the chemical composition of the leaves of Ocimum sanctum. The leaf samples collected at different times of the day were analyzed by gas chromatography coupled with flame ionization detector (GC-FID). The chromatographic fingerprints of different leaf samples were analyzed by chemometric methods like principal component analysis and hierarchical cluster analysis. No significant difference was found in the chemical compositions of the leaf samples collected at different times of the day. The results lead to a conclusion that O. sanctum does not exhibit diurnal variation in its chemical composition, unlike O. gratissimum

Assessment of suitability of saxagliptin hydrochloride for development of controlled release parenteral formulation by preformulation studies

The main objective of pre-formulation study is to develop the stable, elegant, safe and effective drug delivery system by establishing drug kinetic profile, formulation compatibility with different excipients and physico-chemical parameters of new drug molecules. This could provide key evidence for implementing formulation design or requirement of the molecular alteration. So, in the present study preformulation studies were performed on Saxagliptin Hydrochloride (SXG) to assess its suitability for parenteral formulation. SXG is a potent and selective reversible inhibitor of dipeptidyl peptidase-4 used to treat type –II diabetes mellitus. The authenticity of SXG was established by differential scanning calorimetry (DSC) and fourier transform infrared spectroscopy(FTIR) spectra. An ultraviolet–visible (UV) spectrophotometric and high performance liquid chromatography (HPLC) methods were employed for determination of SXG in bulk API (active pharmaceutical ingredient). The UV method was linear within the range of 1-40 μg/ml. The proposed methodology is robust which can be concluded from the lower percentage standard deviation percentage co efficient of variance (% CV) values of intraday and inter day variability. The retention time was observed 1.3 min of SXG in HPLC method. The higher regression coefficient value (0.999) indicates the methodology is robust.&nbsp

Assessment of Suitability of Saxagliptin Hydrochloride for Development of Controlled Release Parenteral Formulation by Preformulation Studies

The main objective of pre-formulation study is to develop the stable, elegant, safe and effective drug delivery system by establishing drug kinetic profile, formulation compatibility with different excipients and physico-chemical parameters of new drug molecules. This could provide key evidence for implementing formulation design or requirement of the molecular alteration. So, in the present study preformulation studies were performed on Saxagliptin Hydrochloride (SXG) to assess its suitability for parenteral formulation. SXG is a potent and selective reversible inhibitor of dipeptidyl peptidase-4 used to treat type –II diabetes mellitus. The authenticity of SXG was established by differential scanning calorimetry (DSC) and fourier transform infrared spectroscopy(FTIR) spectra. An ultraviolet–visible (UV) spectrophotometric and high performance liquid chromatography (HPLC) methods were employed for determination of SXG in bulk API (active pharmaceutical ingredient). The UV method was linear within the range of 1-40 μg/ml. The proposed methodology is robust which can be concluded from the lower percentage standard deviation percentage co efficient of variance (% CV) values of intraday and inter day variability. The retention time was observed 1.3 min of SXG in HPLC method. The higher regression coefficient value (0.999) indicates the methodology is robust.&nbsp