• Validated Stability Indicating Spectrophotometric Method for Estimation of Degradation Behavior of Pyrimethamine and Sulphadoxine in Tablet Formulation

      A new, simple, rapid and novel stability indicating spectrophotometric method has been developed and validated for estimation of degradation behavior of pyrimethamine and sulphadoxine in tablet formulation. For this, first order derivative method is used. The method involved measurement of absorbance at two wavelengths 273.8 nm and 262.5 nm of pyrimethamine and sulphadoxine respectively. This method obeys Beer’s law in the employed concentration ranges of 1-6 µg/ml and 4-24 µg/ml for pyrimethamine and sulphadoxine respectively. Beer's law was obeyed in this concentration range with correlation coefficient of 0.997 and 0.998 for pyrimethamine and sulphadoxine respectively. The accuracy and precision of the method were determined and validated according to ICH guidelines. The method has good reproducibility with percent relative standard deviation (% RSD) less than two. The proposed method was validated for accuracy, precision, linearity, limits of detection (LOD), quantitation (LOQ) and reproducibility. The observations were found within the limits, stability study was performed for both drugs by using acid, base, neutral hydrolysis, oxidation, thermal and photolytic degradations which indicate the stability indicating property of the method. The proposed method is recommended for routine analysis work since it is rapid, simple, accurate, specific and sensitive. Download
    • Validated High Performance liquid Chromatographic Method for Estimation of Thiocolchicoside, and its Application to Ex-vivo Permeation Studies for Transdermal Therapeutic Systems

      A simple, accurate and sensitive high performance liquid chromatography (HPLC) method for estimation of thiocolchicoside (THC) in skin permeated samples was developed and validated. The chromatographic separation was accomplished on a C 18 column (Inertsil ODS 3V C-18, 250 × 4.6 mm, 5 µ )using a mixture of Buffer: Methanol (45:55) as mobile phase. The flow rate was fixed at 1.5 mL/min. The linearity range for the proposed method was 0.25-50µg/mL. Photodiode array detector was set at a wavelength of 264nm to monitor the elution. The LOD and LOQ for thiocolchicoside were 0.05µg/mL and 0.125µg/mL respectively. The correlation coefficient (‘r’2) values were found to be >0.996 and % RSD values for intra-day and inter-day were found to be less than 10%. The method was validated for linearity, specificity, accuracy, precision, robustness, LOD and LOQ as per ICH guidelines and was suitable for estimation of thiocolchicoside in ex-vivo skin diffusate samples and transdermal patches. Download
    • Virosomes : New Frontier for Targeting Drugs and Biological Molecules

      Over the last decade, there has been a great revolution in drug delivery technologies. Delivery of drugs and biological molecules using virosomes is a novel technique available these days. Virosomes are the unilamellar phospholipid bilayer vesicles containing virus derived proteins. They show the targeted action by fusing with the target cell. They may be used as vaccines or vehicle for cellular delivery of macromolecules. Along with the delivery of these substances, it also helps in potentiating immune response. The success of virosomal drug delivery depends upon the method of preparation, use of proper detergents and short chain phospholipids, and function of hemagglutinins. Several parameters are studied regarding their morphology, safety, efficacy and stability. It is also observed that virosomes are showing greater target specificity in combating ebola infection. Though it is a novel, effective drug delivery mechanism, advanced research is needed to use virosomes as a powerful tool. Download
    • Validation and Development of New RpHPLC Methods of Levosulphiride Pellets

      A simple, economic, selective, precise, Reverse phase High Performance Liquid Chromatography method for analysis of levosulphride pellets 40%, was developed and validated according to ICH guidelines. The quantification of the drug was carried out using grace smart, 250mm × 4.6mm × 5μm or its equivalent in isocratic mode, with mobile phase compressing of Buffer : Acetonitrile (70:30) The flow rate was 0.8ml/min and the detection was carried out by PDA detector i.e., 237 nm. The retention time for levosulphride pellets was found to be 2.3 min. The percent assay was found to be 98.98%. The method of levosulphride pellets validated for precision, accuracy, linearity range, specificity and robustness. Download