Validate Precise Rp- Hplc Method For The Simultaneous Estimation  Of Diazepam And Propranolol HCL

J. Madhavi Latha; Ch. Swarna Latha; D. Jeevan Mani Babu; R. Mercy Rani

doi:10.61096/ijamscr.v13.iss1.2025.71-81

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Vol. 13 No. 1 (2025): 2025 Volume -13 - Issue 1

Issue Published : May 1, 2025

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Submitted

March 14, 2025

Published

March 14, 2025

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Validate Precise Rp- Hplc Method For The Simultaneous Estimation Of Diazepam And Propranolol HCL

https://doi.org/10.61096/ijamscr.v13.iss1.2025.71-81

J. Madhavi Latha

Associate Professor, Department of Pharmaceutical Analysis, St.Xavier Institute of Pharmacy, Deenapur, Phirangipuram, Andhra Pradesh, Pin code:522529.

Ch. Swarna Latha

Department of Pharmaceutical Analysis, St.Xavier Institute of Pharmacy, Deenapur, Phirangipuram, Andhra Pradesh, Pin code:522529.

D. Jeevan Mani Babu

Principal, Department of Pharmacology, St.Xavier Institute of Pharmacy, Deenapur, Phirangipuram, Andhra Pradesh, Pin code:522529.

R. Mercy Rani

Department of Pharmaceutical Analysis, St.Xavier Institute of Pharmacy, Deenapur, Phirangipuram, Andhra Pradesh, Pin code:522529.

Corresponding Author(s) : J. Madhavi Latha

madhavilathajonnakuti@gmail.com

International Journal of Allied Medical Sciences and Clinical Research, Vol. 13 No. 1 (2025): 2025 Volume -13 - Issue 1
Article Published : March 14, 2025

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.

Keywords

HPLC Impurities Method development Validation

J. Madhavi Latha, Ch. Swarna Latha, D. Jeevan Mani Babu, R. Mercy Rani. Validate Precise Rp- Hplc Method For The Simultaneous Estimation Of Diazepam And Propranolol HCL. Int. J. of Allied Med. Sci. and Clin. Res. [Internet]. 2025 Mar. 14 [cited 2025 May 14];13(1):71-8. Available from: https://ijamscr.com/ijamscr/article/view/1565

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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.

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.