Dissolution Enhancement of Loratadine by Formulating Oleic Acid and Cremophor EL Based Self Emulsifying Drug Delivery System (SEDDS).

For this experiment, Oleic Acid and Cremophor EL based Loratadine SEDDS were prepared. Different amount of solvent and surfactant were used to prepare SEDDS. After preparation of different formulations their dissolution studies were performed at 50-rpm, paddle method in which dissolution medium was maintained at 37°C (0.5°C) temperature by using Dissolution Tester USP II. Three capsules from each formulation were used in each dissolution study and the release profile of Loratadine was monitored up to one hour. For the formulation development with fixed dose Loratadine (10 mg) and varying amounts of oleic Acid and Cremophor EL were used. In the experiment major determinant is found to be surfactant concentration. In all cases it is found that higher surfactant concentration increased the drug release. Other two determinant factors are amount of Oleic acid and percent drug loading. It was observed that without Cremophor EL, drug release from the formulation was slow. The rate and extent of drug release increased from the matrices with increasing the amount of Cremophor EL in the formulation.

Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Domperidone and Naproxen in Tablet Dosage Form.

A simple, selective and rapid reversed phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and validated for the simultaneous analysis of domperidone and naproxen in tablet dosage form. The chromatographic system consisted of two LC-20 AT pump, SPD-20A UV detector, SIL-20A auto-sampler and CTO- 10ASVP column oven. Chromatographic separation of drugs was achieved on an Shim-Pack C18 column (250 mm x 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of phosphate buffer (pH adjusted to 3.00 with sodium hydroxide): methanol in the ratio 30:70 (v/v) at a flow rate of 1.0 ml/min with UV detection at 280 nm. Retention time was 3.17 minutes for domperidone and 5.42 minutes for naproxen. The method was found selective and peaks of domperidone and naproxen were well separated (resolution 10.72). The proposed method is linear (r2 = 0.999 for domperidone and naproxen), accurate with 99.5% recovery for domperidone and 99.39% recovery for naproxen and precise (%RSD < 1%). The method has been used to determine potency of commercial product and potency was found within limit. The method can be used for the analysis of domperidone and naproxen in tablet dosage form.