Nanosuspension contains submicron colloidal dispersion of pharmaceutical active ingredient particles in a liquid phase stabilized by surfactants. The poor water solubility of drugs is major problem for drug formulation. The reduction of drug particles into the sub-micron range leads to a significant increase in the dissolution rate, bioavailability as well as improve stability. Nanosuspension consists of the pure poorly water-soluble drug without any matrix material suspended in dispersion. Nanosuspension many attempts have been made to deliver poorly water soluble drugs as a nanosuspension prepared by adopting various methods. Techniques such as media milling and high pressure homogenization have been used commercially for producing nanosuspension. Recently, engineering of nanosuspension employs emulsions and microemulsion as templates. The unique features of nanosuspension have enabled their use in various dosage forms, including specialized delivery systems such as mucoadhesive hydrogels, parenteral, peroral, ocular and pulmonary routes.

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Introduction: Dyslipidemia-hypertension proves to be a major risk factor for cardiovascular diseases. In order to achieve better adherence and cost-effectiveness than free equivalent combination therapies, a fixed-dose combination therapy with telmisartan (TEL), rosuvastatin calcium (ROS) and amlodipine besylate (AML) is required in this type of patients.  Aim: A simple, selective and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in synthetic mixture.  Materials and methods: Chromatographic separation was performed on a reversed-phase Luna C18 100Å column (250 mm × 4.6 mm i.d., particle size 5 μ) using an isocratic elution of mobile phase consisting of methanol and acetonitrile (pH 3.5 adjusted by ortho-phosphoric acid) (60:40 v/v) at a flow rate of 1.0 ml/min.  Results: Ultraviolet (UV) detection was performed at 242 nm and retention time of telmisartan, rosuvastatin calcium and amlodipine besylate was found to be 2.67, 4.70, and 7.44 min, respectively. The calibration curve was linear (correlation coefficient >0.999) in the selected range of analyte.  Conclusions: The method was validated for accuracy, precision, linearity, limit of detection, limit of quantitation and ruggedness. The system suitability parameter, such as theoretical plate, asymmetry, and resolution between standard five replicate were well within the limits.