Abstract
Analytical chemistry is a specialized branch of chemistry that deals with methods/protocols/tools for quantitative and qualitative analysis of natural and synthetic materials and thus supposed to be mother of pharmaceutical sciences [1].
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
Christian GD (2004) Analytical chemistry, 6th edn. Wiley, New York, pp 1–4
Anjaneyulu Y, Chandrashekhar K (2006) A textbook of analytical chemistry, 4th edn. Pharma Book Syndicate, Hyderabad, pp 1–5
Garatt DC (2005) The quantitative analysis of drugs, 3rd edn. CBS Publishers and Distributors, New Delhi, p 876
Sethi PD (2001) HPLC quantitative analysis of pharmaceutical formulation, 1st edn. CBS Publisher and Distributer, New Delhi, pp 94–95
Skoog DA, West DM, Holler FJ, Crouch SR (1992) Fundamental of analytical chemistry, 4th edn. Thomson Publisher, Belmont, pp 10–25
Settle FA (2004) Instrumental techniques for analytical chemistry., 1st Indian Reprint. Pearson Education, Denver, pp 147–152
Krustulovic AM, Browm PR (1982) Reversed phase high performance liquid chromatography, 8th edn. Wiley, New York, pp 345–350
Skoog DA, West DM, Holler FJ, Crouch SR (2005) Fundamentals of analytical chemistry, 8th edn. Thomson Publishers, Belmont, pp 986–991
Schirmer RE (2000) Modern methods of pharmaceutical analysis, 2nd edn. CRC Press, Boca Raton, pp 156–159
Khopkar SM (2008) Basic concepts of analytical chemistry, 3rd edn. New Age International Publisher, New Delhi, p 198
Green MJ (1996) A practical guide to analytical method validation, 4th edn. Thomson Publishers, London, pp 305–310
Streeter AJ, Ohannesian L (2005) Handbook of pharmaceutical analysis, vol 117. Marcel Dekker, New York, pp 92–98
Singh S, Garg S (1999) Analytical method validation, 6th. Pharma Times, pp 15–20
Willard HH, Meritt L, Dean JA, Settle FA (1986) Instrumental method of analysis, 7th edn. CBS Publishers and Distributors, New Delhi, pp 586–643
Chan C, Lam YC (2004) Analytical method validation and instrumental performance verification. Wiley, New York, p 75
Billiet HH, Rippel G (1998) Method development and selectivity optimization in high performance liquid chromatography, 9th edn. Marcel Dekker, New York, p 263
Watson DG (2005) Pharmaceutical analysis, 2nd edn. Elsevier Churchill Livingstone, London, pp 276–280
ICH Harmonized Tripartite Guidelines (1994) Text on Validation on Analytical Procedure (Q2A)
ICH Harmonized Tripartite Guidelines (1996) Validation on analytical procedure. Text and Methodology Q2 B (R1), Parent Guidelines
CDER Reviewer Guidance (1994) Validation of chromatographic methods
Braun RD (2006) Introduction to instrumental analysis, 3rd edn. Pharma Book Syndicate, Hyderabad, pp 869–870
Sharma BK (2004) Instrumental methods of chemical analysis, 23rd edn. Goel Publishing House, New Delhi, pp 292–302
Kar A (2001) Pharmaceutical drug analysis, 1st edn. New Age International (P) Ltd. Publishers, New Delhi, pp 211–218
Beckett AH, Stenlake JB (2001) Practical pharmaceutical chemistry, Part-II, 4th edn. CBS Publishers & Distributors, New Delhi, pp 284–285
Dong M, Paul R, Gershanov L (2001) Getting the peaks perfect: system suitability for HPLC. Todays Chemist at Work. 10(9):38–42
FDA (1987) Guidelines for Submitting Documentation for the Stability of Human Drugs and Biologics, Center for Drugs and Biologics, Department of Health and Human Services
Ahuja S, Scypinski S (2005) Handbook of modern pharmaceutical analysis, vol 393, 5th edn. Elsevier, San Diego, p 448
Carstensen JT, Rhodes CT (2000) Drug stability: principles and practices, 2nd edn. Marcel Dekker, New York, pp 167–170
Yoshika S, Stella VJ (2006) Stability of drugs and dosage forms. Springer, New Delhi, pp 5–8
Kim HB (2009) Handbook of stability testing in pharmaceutical development, regulation methodology and best practices. Springer Sciences, New York, p 148
Sehrawat R, Maithani M, Singh R (2010) Regulatory aspects in development of stability-indicating methods: a review. Chromatographia 1(2):1–6
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer Nature Singapore Pte Ltd.
About this chapter
Cite this chapter
Maithani, M., Bansal, P. (2019). Introduction. In: Development of Novel Stability Indicating Methods Using Liquid Chromatography. Springer, Singapore. https://doi.org/10.1007/978-981-13-8723-4_1
Download citation
DOI: https://doi.org/10.1007/978-981-13-8723-4_1
Published:
Publisher Name: Springer, Singapore
Print ISBN: 978-981-13-8722-7
Online ISBN: 978-981-13-8723-4
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)