Combined and comparative analytical studies with stability studies and validation for estimation of prenoxdiazine HCl in pharmaceutical dosage form

Abstract

Abstract Background A precise, accurate, economical and reproducible UV, RP-HPLC and UPLC method has been developed for the estimation of Prenoxdiazine hydrochloride in pharmaceutical and bulk dosage form. Each of the developed method has been validated for the analysis of Prenoxdiazine hydrochloride. Result The validation of the analytical methods was carried out based on various parameters like precision, linearity, accuracy, specificity, LOD, and LOQ for all the three methods. The parameters were found statistically significant for the analysis of Prenoxdiazine hydrochloride. The method was found sensitive in the presence of analytical impurities. The retention time of the Prenoxdiazine HCl was found to be 2.5 and 2.9 min, using common solvents acetonitrile and methanol, in UPLC and HPLC, respectively. Conclusion The method may be useful in the wide range of analysis for the estimation of Prenoxdiazine hydrochloride. It is found to be robust upon the change in solvent flow rate, column temperatures. Further, the study has investigated the stability of the sample under stressed condition like thermal, oxidative, and photolytic. Here, we tried to develop and compare cost-effective methods for Prenoxdiazine HCl using most common industrial methods which are never studied.

Keywords

• Prenoxdiazine HCl
• Libexin
• UPLC and HPLC
• Validation
• Stability studies