Method development and validation of candesartan cilexetil in bulk drug by RP-HPLC

Authors

  • Nasema Begum Department of Quality Assurance, Sultan-Ul-Uloom College of Pharmacy, Banjara Hills, Hyderabad - 500 034. Telangana State, India.
  • Parbati Kirtania Roy Department of Quality Assurance, Sultan-Ul-Uloom College of Pharmacy, Banjara Hills, Hyderabad - 500 034. Telangana State, India.
  • Mohd. Amrin Sultana Department of Quality Assurance, Sultan-Ul-Uloom College of Pharmacy, Banjara Hills, Hyderabad - 500 034. Telangana State, India.

Keywords:

RP-HPLC, CDC, Method Development, Validation.

Abstract

Candesartan Cilexetil (Candesartan) is a medication utilized for the treatment of Hypertension. The main objective of the present work is to determine a simple, precise, accurate RP-HPLC method. In RP-HPLC, the method was developed (Waters Alliance 2690 with PDA detector) at 250nm. The mobile phase used was Methanol: Water (75:25) and Inertsil C18 ODS (4.6×150mm, 5µ) column was used for separation with a flow rate of 1.0 ml/min. The method was validated for System suitability, Specificity, linearity, accuracy, precision, limit of detection, limit of quantification, Robustness. The linearity was observed in a concentration range of 20-70ppm. The %RSD was found to be <2.0% in all cases and all the validation parameters were found to be within the limits. The proposed method was suitable for the quantitative determination of Candesartan Cilexetil in bulk drug.

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Published

2022-09-13