Shaikh Gazi

The aim of the research study was the development and validation of a simple, rapid, accurate and precise reversed-phase high performance liquid chromatography (RP-HPLC) stability-indicating method for the determination of aceclofenac in bulk and pharmaceutical dosage forms. The RP-HPLC studies was performed on the instrument Jasco HPLC system with Jasco UV 2010 photo diode array detector, ODS C18 RP-column (Intersile 250 mm × 4.6 mm; i.d. 10 μm), Rheodyne injection syringe with 20µL loop volume and windows based chrompass software was used for separation. The isocratic elution was performed using the mobile phase ratio of methanol: water (65:35 v/v) and UV detection wavelength at 263 nm. The overall run time of the analysis was 20 minutes and the flow rate was 1.0 mL/min. The RP-HPLC method developed for analysis of aceclofenac was validated as per the ICH guidelines with respect to specificity, selectivity, linearity, accuracy, precision and robustness. The linearity for developed method was observed in the concentration range of 5-50 μg/mL with the correlation coefficient (r2) of 0.9992. The percentage accuracy of aceclofenac ranged from 99.40 to 100.79%. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of aceclofenac was determined in tablet dosage form was found to be within limits. Aceclofenac was subjected to stress conditions such as neutral, acidic, alkaline, oxidation, and photolysis degradations as per ICH guidelines. The results of degradation studies revealed that the drug degraded a maximum (32.68%) in acidic conditions followed by alkaline conditions (15.05%). The drug was found to be resistant towards neutral, acidic and photolytic degradation conditions.

The present research has been undertaken with the aim to formulate and evaluate the low cost herbal gel containing Rubia cordifolia root extract. The gel formulation was designed by using ethanolic extract of Rubia cordifolia root in varied concentrations (750 mg, 1000 mg&1250 mg) and evaluated using physiological measurements. The gel was prepared by using various polymer bases (HPMC K4, HPMC K15, and Carbopol 934). Among them Carbopol 934 has given better gel formation. The gel was prepared by using Carbopol 934, Rubia cordifolia root extract, Propylene glycol 400, Methyl paraben, Propyl paraben and required amount of distilled water. Then skin pH (6.8-7) was maintained by drop wise addition of triethanolamine. The physiochemical parameters of formulations (pH, viscosity, spreadability etc.) were determined. Stability studies have carried out as per ICH guidelines for 3 months at different temperatures and humidity. The results showed that formulation containing 750 mg Rubia cordifolia root extract have better stability than other formulation. Further all formulations have studied for skin irritation on animal model (Rabbit) and result showed that there was no skin irritation to animals.