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International Journal of Pharmaceutical InvestigationNOW IN
Article

Simultaneous Estimation of Amlodipine and Enalapril Maleate by Stability Indicating UHPLC Method

Neha Gaikwad1★, Charushila Bhangale2, Sangita Bhandare3★ Corresponding author

  1. 1Department of Pharmaceutical Quality Assurance, PRES’s College of Pharmacy (For Women), Chincholi, Nashik, Maharashtra, INDIA.
  2. 2Department of Pharmaceutical Chemistry, PRES’s College of Pharmacy (For Women), Chincholi, Nashik, Maharashtra, INDIA.
  3. 3Department of Pharmaceutical Pharmacology, PRES’s College of Pharmacy (For Women), Chincholi, Nashik, Maharashtra, INDIA.

CORRESPONDENCE

Neha Gaikwad

Department of Pharmaceutical Quality Assurance, PRES’s College of Pharmacy (For Women), Chincholi, Nashik, Maharashtra, INDIA.

charushila.bhangale@pravara.in

Received: 07-07-2023; Revised: 28-08-2023; Accepted: 07-10-2023.

Volume 14, Issue 1 · pp. 151–159 · PUBLISHED · DOI: 10.5530/ijpi.14.1.19

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ABSTRACT

Objectives: The key objective of this work is to establish a stability-indicating UHPLC technique for measuring amlodipine and enalapril maleate in bulk and pharmaceutical formulations Materials and Methods: The mobile phase consisted of 0.02M KH2 PO4 buffer: Methanol (70:30 v/v). The chromatographic separation was carried out using an Analytical Technologies UHPLC-3000 equipment in conjunction with a variable wavelength programmable UV identifier and a Rheodyne injector equipped with a 5 µL fixed circle. Detection was done at 224 nm with the flow rate of 0.3 mL/min. Results:Amlodipine's retention time was determined to be 0.7 min, while Enalapril's was 1.2 min. The linearity range for Amlodipine and Enalapril was discovered to be 5–25 µg/mL. The technique has been examined in accordance with ICH (International Conference on Harmonisation) standards. A procedure is precise and accurate if the %RSD is less than two. Amlodipine's limit of detection and quantitation ranges are 0.12–0.37 µg/mL and Enalapril's range is 0.10–0.30 µg/mL, respectively. The procedure proved to be simple, linear, swift, exact, accurate, repeatable, and reliable. The drug was prone to acid, basic, and oxidation conditions, according to the stress degradation research.Conclusion: Even in actual samples, the techniques clearly distinguished between the drugs and degradation products. The method was proved as a stability indicating method and can be used in practice for bulk and the dosage forms and also to evaluate the shelf life.

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    Gaikwad, N., Bhangale, C., & Bhandare, S. (). Simultaneous Estimation of Amlodipine and Enalapril Maleate by Stability Indicating UHPLC Method. International Journal of Pharmaceutical Investigation, 14(1), 151–159. https://doi.org/10.5530/ijpi.14.1.19