A Novel Analytical Method for Simultaneous Quantification of Silodosin and Tadalafil by RP-HPLC

The Reverse phase HPLC method was developed for simultaneous determination of Silodosin and Tadalafil in single analytical method. Chromatographic separation was achieved on a Supelco C8 (150mmx4.6mm, 5µm) column applying an isocratic elution based on premix of potassium phosphate dibasic buffer pH (4.3) and acetonitrile in the ratio of (70:30 v/v) as mobile. Validation parameters specificity, precision and robustness have been observed to be desirable over the concentration ranges of 80-240 µg/ml for Silodosin and 50-150 µg/ml for Tadalafil in accuracy parameter and 128-192 µg/ml for Silodosin and 80-120 µg/ml for Tadalafil in linearity parameter. All the variables have been studied to optimize the chromatographic conditions. The optimized approach verified through validation and confirmed to be intended purpose for the quality control of the mentioned drugs, as per ICH guidelines. For simultaneous quantification of Silodosin and Tadalafil, the developed method was found to be genuinely exact precise, accurate, linear, fast and cost effective.

Validation of Methods of Identification and Quantitative Determination of Active Ingredients in Films for Treatment of Caries of Dentin

Introduction. Even though a wide range of the products for caries treatment is available, the efficiency of its treatment with the traditional methods is 62,5–75,4%. As a result of the set of researches carried out at the Department of Pharmaceutical Technology of the Perm State Pharmaceutical Academy, in cooperation with the Department of Dentistry of the Advanced Training and Professional Retraining Faculty of E. A. Wagner Perm State Medical University, a medical method of moderate and advanced caries treatment with remineralizing gel and films is proposed. During the preparation of the product specification file for the dentin caries treatment film, validation of the methods of the active ingredients quality control has been undertaken.Aim. Validation of the methods of identity tests and of potency assays of dentin caries treatment films.Materials and methods. In order to achieve the aim, active pharmaceutical substances of pharmacopoeial quality have been used. As a base for developing the methods of identity tests the methods with distinctive reactions to cations and anions have been taken. For the potency assay of calcium chloride a complexometric back-titration has been used; photoelectric colorimetry for potassium phosphate dibasic and sodium fluoride; spectrophotometry for chlorhexidine bigluconate. Five production samples of the films were the object of the research.Results and discussion. Basing on the research results, the choice was made in favour of the methods of identity tests that are characterized by negative analytical response when applied to the model mixtures which are free from analyte and placebo, and by positive analytical response when applied to the model mixtures of various composition containing analyte. The validation characteristics of the methods of dentin caries treatment films potency assays, which may be included in the product specification file, have been studied.Conclusion. Validation results show that the chosen methods are specific for both identity tests and potency assays of active substances in the dentin caries treatment films; they are characterized by precision, repeatability and linear dependency in the analytical range of ±30% in regard to the specified active substance concentration in the films. All that allows using them for a reliable quality assessment.

Fungitoxic effect of inorganic salts for the management of seed borne Macrophomina phaseolina and Fusarium sp. causing charcoal rot and wilt disease in blackgram

The laboratory experiments were carried out to study the effect of different salts viz., potassium chloride (KCl), potassium phosphate dibasic (K2HPO4), sodium carbonate (Na2CO3), sodium bicarbonate (NaHCO3) and ammonium molybdate (NH4)6 Mo7O24) on seed borne M. phaseolina and Fusarium sp. as an alternative to synthetic fungicides for the control of charcoal rot and wilt diseases in blackgram. The evaluation of different salts was performed in vitro using various concentrations viz., 0.5, 1.0, 2.0, 4.0 and 8.0 per cent (w/v). Among the salts tested against M. phaseolina, sodium carbonate, sodium bicarbonate and ammonium molybdate at 0.5, 2.0 and 4.0 per cent respectively inhibited the fungal growth. Among the salts tested against Fusarium sp. sodium carbonate (Na2CO3) at 4.0 per cent concentration recorded complete inhibition of the mycelial growth compared to the other salts. Also seed priming of these salts significantly reduced the seed borne infection due to M. phaseolina and Fusarium sp. under standard blotter test. The salts like potassium chloride and potassium phosphate dibasic (K2HPO4) at all concentrations did not inhibit M. phaseolina and Fusarium sp. which recorded 100 per cent mycelial growth as that of control.