A Review On Development And Validation Of Hplc Method For Analysis Of Pharmaceutical Drug
Keywords:
Development, Validation, HPLC Method, Analysis and Pharmaceutical DrugAbstract
High-Performance Liquid Chromatography (HPLC) is the predominant method employed for the detection, separation, and quantification of pharmaceuticals. To enhance the methodology, many chromatographic parameters were examined, including sample pre-treatment, mobile phase selection, column selection, and detector selection. This article aims to discuss the processes of method development, optimisation, and validation. The HPLC method is advantageous due to its speed, specificity, accuracy, precision, and ease of automation, making it suitable for analysing most medicines in multicomponent dosage forms. The development and validation of HPLC methods are essential in the discovery, development, and production of novel drugs, as well as in many human and animal investigations. Validation of analytical methods is essential during medication development and production to confirm that these procedures are suitable for their intended purpose. To comply with GMP standards, pharmaceutical industries must establish a comprehensive validation policy outlining the validation process. This article focusses on the optimisation of HPLC conditions.
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Kumar SD, Kumar DH. Importance of RP-HPLC in analytical method development: a review. International Journal of Pharmaceutical Sciences and Research. 2012 Dec 1; 3(12):4626.
Jagdale, A. S., Pendbhaje, N. S., Nirmal, R. V., Bachhav, P. M., & Sumbre, D. B. (2021). Development and validation of RP-HPLC method for estimation of brexpiprazole in its bulk and tablet dosage form using Quality by Design approach. Future Journal of Pharmaceutical Sciences, 7(1), 1-12.
Beg S, Kohli K, Swain S, Hasnain MS. Development and validation of RP-HPLC method for quantitation of amoxicillin trihydrate in bulk and pharmaceutical formulations using Box-Behnken experimental design. Journal of Liquid Chromatography & Related Technologies. 2012 Feb 1; 35(3):393-406.
Lawrence XY, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J. Understanding pharmaceutical quality by design. The AAPS journal. 2014 Jul; 16(4):771-83.
U. S. Food and Drug Administration. Guidance for Industry: Q8 (2) Pharmaceutical Development. 2009
Kirthi, A., Shanmugam, R., Prathyusha, M. S., & Basha, D. J. (2014). A review on bioanalytical method development and validation by RP-HPLC. Journal of global trends in pharmaceutical sciences, 5(4), 2265-2271.
Arayne, M. S., Sultana, N., & Zuberi, M. H. (2006). Development and validation of RP-HPLC method for the analysis of metformin. Pak J Pharm Sci, 19(3), 231-5.
Murugan S, Elayaraja A, Chandrakala K, Ramaiah P, Vulchi C. A Review on Method Development and Validation by Using HPLC. International journal of novel trends in pharmaceutical sciences. 2013 Jul 10; 3(4):78-81.
Surve DH, Jindal AB. Development and validation of reverse-phase high-performance liquid chromatographic (RP-HPLC) method for quantification of Efavirenz in Efavirenz-Enfuvirtide co-loaded polymer-lipid hybrid nanoparticles. Journal of pharmaceutical and biomedical analysis. 2019 Oct 25; 175:112765.
Mohd AB, Sanka K, Gullapelly R, Diwan PV, Shastri N. Development and validation of RP-HPLC method for glimepiride and its application for a novel self-nanoemulsifying powder (SNEP) formulation analysis and dissolution study. Journal of analytical science and technology. 2014 Dec; 5(1):1-8.
Bhadra S, Das SC, Roy S, Arefeen S, Rouf AS. Development and validation of RP-HPLC method for quantitative estimation of vinpocetine in pure and pharmaceutical dosage forms. Chromatography Research International. 2011 Nov 15; 2011.
Venkateswararao Y, Sujana K. A novel stability indicating Rp-Hplc method development and validation for the determination of clopidogrel in bulk and its dosage forms. International Journal of Pharmacy Research & Technology. 2019; 9(2):1-1.
Anjaneyalu Y, Chandrasekhar K, ValliManickam. Text book of Analytical Chemistry, pg.: 273-278., 2006.
Gupta V, Jain A D K, Gill N S, Gupta K. Development and validation of HPLC method - A review, Int. Res J Pharm. App Sci, 2(4), 2012, 17-25.
Rao BV, Sowjanya GN, Ajitha A, Rao Uma MV. A review on stability-indicating HPLC method development, World journal of pharmacy and pharmaceutical sciences.2015; 4(8):405-423.
Rajan HV. Development and validation of HPLC method - A Review. International Journal of current research in pharmacy. 2015; 1(2):55-68.
Kumar V, Bharadwaj R, Gupta G, Kumar S. An Overview on HPLC Method Development, Optimization and Validation process for drug analysis. The Pharmaceutical and Chemical Journal. 2015; 2(2):30-40.
B.V. Rao, G.N. Sowjanya1, A. Ajitha, V.U.M. Rao, Review on stability indicating HPLC method development, World Journal of Pharmacy and Pharmaceutical Sciences, 4(8) (2015) 405-423.
Arpino, Patrick.1992: Combined liquid chromatography-mass spectrometry. Part III. Applications of thermospray”. Mass Spectrometry Reviews, 11: 3. doi:10.1002/mas.1280110103.
Gupta V, Jain AD, Gill NS, Gupta K. Development and validation of HPLC method - a review. International Research Journal of Pharmaceutical and Applied Sciences. 2012; 2(4):17-25.
Sonia K, Nappinnai M. Development and validation of HPLC and UV-visible spectrophotometric method for the pharmaceutical dosage form and biological fluid –review. European Journal of Biomedical and Pharmaceutical sciences. 2016; 3(3): 382-391
9. Sánchez MLF. Chromatographic techniques, European RTN Project, GLADNET, retrieved on 05-09-2013.
HPLC – Chemiguide. May 2, 2007. www.chemguide.co.uk
United States Pharmacopoeia and National Formulary, (24th) Asian Edition, the United States Pharmacopoeia Convention Inc. U.S.A.2126.
Sankar SR, Text book of Pharmaceutical Analysis. 5th Edition 2006. Rx publications, Tirunelveli. 2006; 13- 1, 2.
S. Sood, R. Bala, N.S. Gill, Method development and validation using HPLC technique – A review, Journal of Drug Discovery and Therapeutics 2 (22) 2014, 18- 24.
M.W. Dong, Modern Hplc for practicing scientists, John Wiley & Sons, New Jersey, 2006.
P.K. Singh, M. Pande, L.K. Singh , R.B. Tripathi, steps to be considered during method development and validation for analysis of residual solvents by gas chromatography, Int. Res J Pharm. App Sci., 3(5) (2013) 74-80.
B. Prathap, G.H.S. Rao, G. Devdass, A. Dey, N. Harikrishnan , Review on Stability Indicating HPLC Method Development, International Journal of Innovative Pharmaceutical Research.3(3) (2012) 229- 237.
B. Sriguru, N.P. Nandha, A.S.Vairale, A.V. Sherikar, V. Nalamothu, Development and validation of stability indicating HPLC method for the estimation of 5- Fluorouracil and related substances in topical formulation, Int. J. Res. Pharm. Sci. 1 (2) (2010) 78- 85.
C.K. Kaushal, B. Srivastava, A process of method development: A chromatographic approach, J. Chem. Pharm. Res. 2(2) (2010) 519-545.
N.Toomula, A. Kumar, S.D.Kumar, V.S. Bheemidi, Development and Validation of Analytical Methods for Pharmaceuticals, J Anal Bioanal Techniques. 2(5) (2011) 1-4.
K. Kardani, N. Gurav, B. Solanki, P. Patel, B. Patel, RP-HPLC Method Development and Validation of Gallic acid inPolyhedral Tablet Formulation, Journal of Applied Pharmaceutical Science. 3 (5) (2013) 37- 42.
B. Nigovic, A. Mornar, M. Sertic, Chromatography – The Most Versatile Method of Chemical Analysis, Intech (2012) 385-425.
T. Bhagyasree, N. Injeti, A. Azhakesan, U.M.V. Rao, A review on analytical method development and validation, International Journal of Pharmaceutical Research & Analysis, Vol 4 (8) (2014) 444-448.
A. Shrivastava, V.B. Gupta, HPLC: Isocratic or Gradient Elution and Assessment of Linearity in Analytical Methods, J Adv. Scient Res, 3(2) (212) 12- 20.
V. Kumar, R. Bharadwaj, G.G., S. Kumar, An Overview on HPLC Method Development, Optimization and Validation process for drug analysis, The Pharmaceutical and Chemical Journal, 2(2) (2015) 30-40.
Validation of Analytical Procedures: Text and Methodology, International Conferences on Harmonization, Draft Revised (2005), Q2 (R1).
Validation of Compendial Procedures, United State Pharmacopeia, USP 36 NF, 27 (2) (2010).
Sriguru B, Nandha N P, Vairale A S, Sherikar A V, Nalamothu V. Development and validation of stability indicating HPLC method for the estimation of 5-Fluorouracil and related substances in topical formulation, Int. J. Res. Pharm. Sci, 1(2), 2010, 78-85.
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