Md. Sabir Azim

Enhancement of the solubility is an important physicochemical parameter which affects the absorption of drug and its therapeutic activity. The poor aqueous solubility of drug affects the lack of formulation development. In this study the antifungal drug ketoconazole were prepared with β-cyclodextrin and PEG-6000 by four different methods with an intention to improve its dissolution properties. Solubility of ketoconazole was prepared by sonocrystallization, solid dispersion, hydrotropy and Inclusion complex formation technique. In vitro release profile were evaluated and compared with standard ketoconazole. Solubility by the hydrotropy method was found to be 12.159 fold increases while by inclusion complex, solid dispersion, and melt sonocrystallization method was found to be 9.644, 7.349, and 5.517 fold respectively. Dissolution profile of all four formulations (aqueous suspension), it was found that the formulation prepared by the hydrotropy method showed the best release profile that is 83.16%. Investigations of the properties of the dispersions were performed using release studies with analytical studies, Differential scanning calorimetery (DSC), and Fourier transform infrared (FTIR). FT‐IR spectra revealed no chemical incompatibility between drug and ß‐cyclodextrin. Interaction of Drug-polymer was investigated using differential scanning calorimetry (DSC).

A simple, accurate, precise and fast reverse phase, gradient RP-HPLC method was developed for the separation of telmisartan and hydrochlorothiazide in combination dosage form of Tablets. The method was carried out by using Kromasil, C18, 4.6 x 150mm, 5 μm enhanced polar selectivity column and mobile phase comprised of potassium dihydrogen phosphate buffer pH adjusted to 3.2 ± 0.5 with orthophosphoric acid and acetonitrile, and degassed under ultrasonication. The flow rate was 1.5 mL/min and the effluent was monitored at 225nm. The retention time of hydrochlorothiazide and telmisartan were 2.7 ± 0.5 and 7.3 ± 0.5 respectively. The method was validated as per ICH guideline. The proposed method is suitable for simultaneous determination of telmisartan and hydrochlorothiazide in pharmaceutical dosage form.