Stability Indicating Validated HPLC Method for the Determination of Aceclofenac and Misoprostol in Bulk and Pharmaceutical Formulation

Abstract

For the simultaneous evaluation of Aceclofenac and Misoprostol using RP-HPLC, an accurate, rapid, economical, and straightforward, reliable assay technique was developed and demonstrated. The proposed method achieved effective chromatographic separation by using an inertsil ODS column (150mmx4.6mm, 3.5), acetonitrile, and 0.1 percent orthophosphoric acid (OPA) (50:50 v/v) as a mobile phase with a flow rate of 1 ml/min and a wavelength of 227 nm. The retention time (Rt) of Aceclofenac was 3.189 minutes and Misoprostol was 6.966 minutes. Chromatography was performed isocratically at room temperature with a run time of around 10 minutes. The suitability parameters of the system were investigated by multiplying the quality six times, and the results were well within acceptable limits. The linearity analysis was conducted at 10 percent to 150 percent stages, with a regression coefficient of 0.999. Aceclofenac and Misoprostol had LOD and LOQ values of 0.063 ug/ml, 0.063 g/ml, and 0.208 ug/ml and 0.208 g/ml, respectively. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits. The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. As a result, it was obvious that the proposed approach was ideal for routine pharmaceutical preparation review and quality control. Validation results were very close to the appropriate maximum. RSD values of less than 2.0 percent indicate that this approach is accurate and precise. The above method was used to perform a retail formulation assay, which showed that 100.24 percent of the formulation was present. Degradation stress conditions in acidic, alkaline, peroxide, and thermal media were investigated. Under ideal conditions, the established method provided efficient, precise, and accurate results. According to ICH guidelines, the approach was justified.

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