ICH guidelines.

A sensitive and reproducible RP-HPLC method was described for the quantitative determination of chlorthalidone and olmesartan in combined dosage form. This method was based on high performance liquid chromatographic (HPLC) separation of chlorthalidone and olmesartan with the use of a reversed phase HPLC column [Hypersil BDS, C18, 100 x 4.6 mm, 5m] at mobile phase consisting of phosphate buffer (pH-3.3) and acetonitrile in the ratio of 55:45 v/v ambient temperature. The flow rate of the mobile phase was adjusted to 1.0mL/min and the injection volume was 10μL. Detection was performed by photodiode array detector at a wavelength of 210nm and the chromatographic runtime was 6 minutes for the analysis. The reliability and analytical performance of the proposed method, including linearity, range, precision, accuracy, detection and quantitation limits, were statistically validated. The proposed method can be useful in the quality control of combination drug products

Mouth dissolving tablets one of the novel approaches in improving patient compliance. Levocetrizine hydrochloride the non-sedative antihistamine drug commonly used for the treatment of allergic rhinitis. Tablet containing levocetrizine with Doshion P54 (C) resin and different superdisintegrants like Sodium starch glycolate, crospovidone, and polacrilin potassium were used for the manufacturing of tablet. Direct compression technique is used for manufacturing of tablet. Combinations of excipients were incorporated to formulate the tablet. Effect of the combinations were studied to optimize the formulation. Compatibility between the drug and excipients were performed with the help of FTIR spectral analysis. The tablets were evaluated for their hardness, wetting time, disintegrating time and dissolution parameters. It was concluded that the tablets having the combination of drug with Sodium Starch Glycolate  and Polacriline Potassium  met all the evaluation parameters and thus selected as the optimized formulation. The optimized formulation was undergone for stability studies in predicting the shelf-life as per ICH guidelines and proved  for its adequate shelf-life. Key words: Mouth dissolving tablet , Levocetrizine hydrochloride, FTIR, ICH guidelines.