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Research & Reviews: A Journal of Pharmacognosy Original Research

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

  1. Vinay Kumar Department of Pharmacy, Millennium College of Pharmacy, Bhopal
  2. Ankita Shukla Department of Pharmacy, Millennium College of Pharmacy, Bhopal
  3. Bala Subramanyam Department of Pharmacy, Millennium College of Pharmacy, Bhopal

Abstract

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

References (13)

  1. Professor and Head, Dept. of Pharmacognosy, The Erode College of Pharmacy, Perundurai Main Road, Veppampalayam, Erode-638112, Tamilnadu, India, RaviKKumar VR, Rathi S, Professor & Principal, School of Pharmacy, Rai University, Ahmedabad, Gujarat, India, Singh S, Assistant Professor, School of Pharmacy, Rai University, Ahmedabad, Gujarat, India, et al. A Comprehensive Review on Ulcer and Their Treatment. Chinese Journal of Applied Physiology. 2023;39:e20230006. doi:10.62958/j.cjap.2023.006
  2. Professor, Patel College of Pharmacy, Madhyanchal Professional University, Ratibad, Bhopal, MP. India, Rajput DS, Gupta N, Professor and Dean, Patel College of Pharmacy, Madhyanchal Professional University, Ratibad, Bhopal, MP. India, Singh S, Ph.D. Research Scholar, Patel College of Pharmacy, Madhyanchal Professional University, Ratibad, Bhopal, MP. India, et al. A Comprehensive Review: Personalized Medicine for Rare Disease Cancer Treatment. Chinese Journal of Applied Physiology. 2023;39:e20230008. doi:10.62958/j.cjap.2023.008
  3. Patel College of Pharmacy, Madhyanchal Professional University, Bhopal, MP. India, Singh S, Chaurasia A, Patel College of Pharmacy, Madhyanchal Professional University, Bhopal, MP. India, Rajput DS, Patel College of Pharmacy, Madhyanchal Professional University, Bhopal, MP. India, et al. Mucoadhesive Drug Delivery System and There Future Prospective: Are a Promising Approach for Effective Treatment? Chinese Journal of Applied Physiology. 2023;39:e20230005. doi:10.62958/j.cjap.2023.005
  4. Sigmapharm laboratories llc, Bensalem, Pennsylvania, USA, Patel S, Y I, Crescent School of Pharmacy, B.S. Abdur Rahman Crescent Institute of Science and Technology, Chennai-600048, Tamilnadu, India, Singh S, GSVM Medical College (MBBS 3rd year Student), Kanpur-208002, Uttar Pradesh, India, et al. Recent Innovations and Future Perspectives in Transferosomes for Transdermal Drug Delivery in Therapeutic and Pharmacological Applications. Chinese Journal of Applied Physiology. 2024:e20240031. doi:10.62958/j.cjap.2024.031
  5. Assistant Professor, Department of Pharmaceutical Sciences, Faculty of Health Sciences, Marwadi University, Rajkot, India, Vaghela MC, Rathi S, Professor and Principal, School of Pharmacy, Rai University, Ahmedabad, Gujarat, India, Shirole RL, Associate Professor, Department of Pharmacology, DCS’s A.R.A. College of Pharmacy, Nagaon, Dhule (MS) India, et al. Leveraging AI and Machine Learning in Six-Sigma Documentation for Pharmaceutical Quality Assurance. Chinese Journal of Applied Physiology. 2024;40:e20240005. doi:10.62958/j.cjap.2024.005
  6. Sigmapharm laboratories llc, Bensalem, Pennsylvania, USA, Patel S, Y I, Crescent School of Pharmacy, B.S. Abdur Rahman Crescent Institute of Science and Technology, Chennai-600048, Tamilnadu, India, Singh S, GSVM Medical College (MBBS 3rd year Student), Kanpur-208002, Uttar Pradesh, India, et al. Recent Innovations and Future Perspectives in Transferosomes for Transdermal Drug Delivery in Therapeutic and Pharmacological Applications. Chinese Journal of Applied Physiology. 2024:e20240031. doi:10.62958/j.cjap.2024.031
  7. Singh, S., Chaurasia, A., Rajput, D. S., & Gupta, N. (2024). An overview on mucoadhesive buccal drug delivery systems & approaches: A comprehensive review. African Journal of Biological Sciences (South Africa), 6(5), 522–541, doi:10.33472/AFJBS.6.5.2024.522-541
  8. Kumar S, Singh S, Rajput D, Sharma B, Chaturvedi K, Singh N, et al. Pharmacological Approaches and Herbal Interventions for Alzheimer's Disease. The Natural Products Journal. 2024;14(8). doi:10.2174/0122103155275266231123090138
  9. Department of Pharmacognosy, The Erode College of Pharmacy,Erode, Tamilnadu, India-638112, Ravikkumar VR, Patel BD, Department of Pharmaceutical Chemistry & Quality Assurance, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, India-382260, Rathi S, Department of Pharmaceutics, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, India-382260, et al. Formulation and Evaluation of Drumstick Leaves Tablet as An Immunomodulator. Chinese Journal of Applied Physiology. 2024;40:e20240004. doi:10.62958/j.cjap.2024.004
  10. Sharma, A., Bara, G., Keshamma, E., Sharma, B., Singh, S., Singh, S. P., Parashar, T., Rathore, H. S., Sarma, S. K., & Rawat, S. (2023). Cancer biology and therapeutics: A contemporary review. Journal of Cardiovascular Disease Research, 14(10), 1229-1247.
  11. Patel College of Pharmacy, Madhyanchal Professional University, Ratibad, Bhopal, MP. India, Singh S, Chaurasia A, Patel College of Pharmacy, Madhyanchal Professional University, Ratibad, Bhopal, MP. India, Gupta N, Patel College of Pharmacy, Madhyanchal Professional University, Ratibad, Bhopal, MP. India, et al. Effect of Formulation Parameters on Enalapril Maleate Mucoadhesive Buccal Tablet Using Quality by Design (QbD) Approach. Chinese Journal of Applied Physiology. 2024;40:e20240003. doi:10.62958/j.cjap.2024.003
  12. Patel SK, Prathyusha S, Kasturi M, Godse KC, Singh R, Rathi S, et al. Optimizing Irbesartan Fast Dissolving Tablets Using Natural Polysaccharides for Enhanced Drug Delivery and Patient Compliance. International Research Journal of Multidisciplinary Scope. 2025;06(01):1181-1190. doi:10.47857/irjms.2025.v06i01.02542
  13. Formulation, optimization and evaluation of mucoadhesive buccal tablets of ondansetron for enhanced bioavailability and sustained drug release. Biochemical and Cellular Archives. 2025;25(1). doi:10.51470/bca.2025.25.1.1063
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