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Validate Precise Rp- HPLC Method for the Simultaneous Estimation of Diazepam and Propranolol HCL
Corresponding Author(s) : J. Madhavi Latha
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 13 No. 1 (2025): 2025 Volume -13 - Issue 1
Abstract
High Performance Liquid Chromatography (HPLC) is a very important analytical tool for the assessments of drug product. HPLC techniques should be able to separate, identify and quantify various medicinal products and related detoriating materials that can form on storage or manufacturing or may be incorporated during the synthesis. Validation is the process of establishing the performance and limitations of any technique and identification of various products which may change their characteristics. This article discusses the strategies and the issues pertinent to modelling of HPLC method development and validation.
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- Amod S. Patil, Atul A. Shirkhedkar, Sanjay J. Surana, Prajakta S. Nawale. Q- Absorbance and Multicomponent UV Spectrophotometric Methods for Simultaneous Estimation of Propranolol Hydrochloride and Flunarizine Dihydrochloride in Capsules. Der Pharma Chemica.2011, 3(3): 404-408.
- Anonymous. 1994. ICH Harmonized Tripartile Guidelines, Text on Validation of Analytical procedure: Text and Methodology.Q2A. Geneva. pp 1-5.
- Anonymous United States Pharmacopoeia. 23/NF, 18, United states of Pharmacopoeia convention, inc, Rock Wille, MD.,1063,1961, 1988 1990.
- Ashutoshkar, Pharmaceutical analysis. CBS publishers and Distributors Pvt. Ltd. 2007: pp 11.
- Becket AH, Stenlake JB. Practical Pharmaceutical Chemistry. Part –II. 4th edition. CBS Publishers and Distributors: New Delhi. 2007: pp 85, 86, 92.
- Chung Chow Chan, Herman Lam, Y.C Lee, XUE-Ming Zhang. Analytical Method Validation and Instrument Performance Verification. A John Wiley and Sons, Inc., Publications.2004: pp 16-22.
- David G. Watson, A Text Book For Pharmacy Students and Pharmaceutical Chemist.
- Churchill and Livingstone Publishers Limited. 1999: pp 195, 201David Harvey, Modern Analytical Chemistry. Published by Mc Graw Hill Higher Education, A Division of The Mc Graw-Hill companies. 2000: pp 2 – 6.
- D. Kealey, P.J. Haines. Instant Notes on Analytical Chemistry. Bios Scientific Publishers Limited. 2002: pp 1-5.
- Douglas A. Skoog, Donald M. West. Principles of instrumental Analysis. 2nd edition. Saunders Golden Sun Burst Series.2007: pp 667, 693-705
- Eleanor I. Miller, Fiona M. Wylie, John S. Oliver. Simultaneous Detection and Quantification of Amphetamines, Diazepam and its Metabolites, Cocaine and its Metabolites, and Opiates in Hair by LC–ESI-MS–MS Using a Single Extraction Method. Journal of Analytical toxicology. 2008, 8(2):457-469.
References
Amod S. Patil, Atul A. Shirkhedkar, Sanjay J. Surana, Prajakta S. Nawale. Q- Absorbance and Multicomponent UV Spectrophotometric Methods for Simultaneous Estimation of Propranolol Hydrochloride and Flunarizine Dihydrochloride in Capsules. Der Pharma Chemica.2011, 3(3): 404-408.
Anonymous. 1994. ICH Harmonized Tripartile Guidelines, Text on Validation of Analytical procedure: Text and Methodology.Q2A. Geneva. pp 1-5.
Anonymous United States Pharmacopoeia. 23/NF, 18, United states of Pharmacopoeia convention, inc, Rock Wille, MD.,1063,1961, 1988 1990.
Ashutoshkar, Pharmaceutical analysis. CBS publishers and Distributors Pvt. Ltd. 2007: pp 11.
Becket AH, Stenlake JB. Practical Pharmaceutical Chemistry. Part –II. 4th edition. CBS Publishers and Distributors: New Delhi. 2007: pp 85, 86, 92.
Chung Chow Chan, Herman Lam, Y.C Lee, XUE-Ming Zhang. Analytical Method Validation and Instrument Performance Verification. A John Wiley and Sons, Inc., Publications.2004: pp 16-22.
David G. Watson, A Text Book For Pharmacy Students and Pharmaceutical Chemist.
Churchill and Livingstone Publishers Limited. 1999: pp 195, 201David Harvey, Modern Analytical Chemistry. Published by Mc Graw Hill Higher Education, A Division of The Mc Graw-Hill companies. 2000: pp 2 – 6.
D. Kealey, P.J. Haines. Instant Notes on Analytical Chemistry. Bios Scientific Publishers Limited. 2002: pp 1-5.
Douglas A. Skoog, Donald M. West. Principles of instrumental Analysis. 2nd edition. Saunders Golden Sun Burst Series.2007: pp 667, 693-705
Eleanor I. Miller, Fiona M. Wylie, John S. Oliver. Simultaneous Detection and Quantification of Amphetamines, Diazepam and its Metabolites, Cocaine and its Metabolites, and Opiates in Hair by LC–ESI-MS–MS Using a Single Extraction Method. Journal of Analytical toxicology. 2008, 8(2):457-469.