Analytical Method Development and Validation of Simultaneous Estimation of Natural Active Constituents Andrographolide and Piperine by UV Method.

Year : 2025 | Volume : 12 | 03 | Page :
    By

    Vinay Kumar,

  • Ankita Shukla,

  • Bala Subramanyam,

  1. Research Scholar, Department of Pharmacy, Millennium College of Pharmacy, Bhopal, Madhya Pradesh, India
  2. Professor, Department of Pharmacy, Millennium College of Pharmacy, Bhopal, Madhya Pradesh, India
  3. Professor, Department of Pharmacy, Millennium College of Pharmacy, Bhopal, Madhya Pradesh, India

Abstract

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A simple, accurate, precise, and robust UV-Visible spectrophotometric method was developed and validated for the simultaneous estimation of Andrographolide and Piperine in bulk and combined pharmaceutical dosage forms. Preformulation studies confirmed favorable physicochemical properties for both drugs, including acceptable solubility profiles, melting points, pH values, and partition coefficients. The method development involved determination of λmax values at 224 nm for Andrographolide and 288 nm for Piperine using ethanol as solvent. The proposed method showed excellent linearity over the concentration ranges of 10–50 µg/mL for Andrographolide and 2–10 µg/mL for Piperine, with correlation coefficients (R²) of 0.999 for both drugs. Validation parameters demonstrated high precision, with %RSD values below 0.3% for repeatability, intraday, and interday precision studies. Recovery studies indicated accuracy within the range of 98–102%. The LOD and LOQ values were 1.95 µg/mL and 5.92 µg/mL for Andrographolide, and 0.40 µg/mL and 1.24 µg/mL for Piperine, confirming method sensitivity. Ruggedness and robustness studies indicated the reliability of the method under varied analytical conditions. The method was successfully validated as per ICH Q2(R1) guidelines and is suitable for routine quality control and simultaneous quantification of Andrographolide and Piperine in pharmaceutical formulations.

Keywords: Andrographolide, Piperine, UV-Visible spectrophotometry, method validation, linearity, accuracy, precision, LOD, LOQ, simultaneous estimation

How to cite this article:
Vinay Kumar, Ankita Shukla, Bala Subramanyam. Analytical Method Development and Validation of Simultaneous Estimation of Natural Active Constituents Andrographolide and Piperine by UV Method.. Research & Reviews: A Journal of Pharmacognosy. 2025; 12(03):-.
How to cite this URL:
Vinay Kumar, Ankita Shukla, Bala Subramanyam. Analytical Method Development and Validation of Simultaneous Estimation of Natural Active Constituents Andrographolide and Piperine by UV Method.. Research & Reviews: A Journal of Pharmacognosy. 2025; 12(03):-. Available from: https://journals.stmjournals.com/rrjopc/article=2025/view=0


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Ahead of Print Subscription Original Research
Volume 12
03
Received 07/07/2025
Accepted 15/07/2025
Published 13/08/2025
Publication Time 37 Days
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