Scientific Publications & Books

DGS Pharmaceutical Consultancy Ltd is built upon a foundation of scientific excellence, technical expertise, and evidence-based practice. Our leadership has authored more than 60 peer-reviewed scientific publications and three books in analytical chemistry, contributing to advances in pharmaceutical sciences, quality systems, regulatory compliance, drug development, and healthcare.

Many of these publications have achieved international recognition and have been among the most cited and most read articles in their respective fields, reflecting a longstanding commitment to scientific innovation, knowledge sharing, and professional excellence.

These contributions demonstrate the depth of expertise that underpins our consultancy services and our commitment to helping pharmaceutical, biotechnology, medical device, and healthcare organisations address complex quality, regulatory, and operational challenges with confidence.

Books

Ghulam Shabir, HPLC method development and validation in pharmaceutical analysis, Handbook for analytical scientists, Lap Lambert Academic Publishing, 2013

Ghulam Shabir, HPLC, LC-MS and GC Method development and validation, Lap Lambert Academic Publishing, 2012

Ghulam Shabir, Practical HPLC and LC-MS method development and validation: Guidelines for pharmaceutical scientist, Lap Lambert Academic Publishing, 2012

Peer-Reviewed Publications

Shabir G.A. A 20 Year Retrospective: The Pharmaceutical Industry Then and Now. Looking ahead what does the industry need to do to address growing concerns over cost, time to market, government/regulatory scrutiny, and quality/safety of products? American Pharmaceutical Review, 15 Oct 2018. Read full article hear: https://www.americanpharmaceuticalreview.com/Featured-Articles/354573-A-20-Year-Retrospective-The-Pharmaceutical-Industry-Then-and-Now/

Journal of Liquid Chromatography & Related Technologies, Publisher: Taylor & Francis, Philadelphia, USA

Shabir, G.A*., Khalida P. Mahar, et.al. A novel HPLC method for the determination of alpha-keto acids in human serum using meso stillbenediamine as derivatization reagent. J. Liq. Chromatogr. Relat. Technol. 2012, 35(9) 1245-1258.

Shabir, G.A., Bradshaw, T.K. Development and validation of reversed-phase LC method for the analysis of methamphetamine and propranolol in tablets. J. Liq. Chromatogr. Relat. Technol. 2012, 35(3) 458-469.

Shabir, G.A. Simultaneous analysis of phenothrin, methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate in human head lice medicine by HPLC. J. Liq. Chromatogr. Relat. Technol. 2011, 34(16)1743-1753.

Shabir, G.A. Simultaneous determination of p-hydroxybenzoic acid, 2-phenoxyethanol, methyl-p-hydroxybenzoate, ethyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, iso-butyl-p-hydroxybenzoate and n-butyl-p-hydroxybenzoate in senselle lubricant formulation by HPLC. J. Liq. Chromatogr. Relat. Technol. 2011, 34(9), 679-689.

Shabir, G.A*., Arain, S.A. Determination of paracetamol, methyl parahydroxybenzoate, ethyl parahydroxybenzoate and propyl parahydroxybenzoate in medicinal suspension and tablets by RPLC/UV-DAD.J. Liq. Chromatogr. Relat. Technol. 2011, 34(9), 719-729.

Shabir, G.A. Development and validation of a stability-indicating LC method for the determination of domperidone, sorbic cid and propylparaben in pharmaceutical formulations. J. Liq. Chromatogr. Relat. Technol. 2010, 33(20), 1802–1813. (Most read and Top most cited article since published to 2012)

Forrow, N.J., Shabir, G.A*. Development and validation of a HPLC method for NAD: Application to stability studies in buffered solutions and dry test strips. J. Liq. Chromatogr. Relat. Technol. 2009, 32(19), 2805 – 2821.

Shabir, G.A*., Bradshaw, T.K., Arain, S.A., Shar, G.Q. A new validated method for the simultaneous determination of a series of eight barbiturates by RP-HPLC. J. Liq. Chromatogr. Relat. Technol. 2010, 33(1), 61–71.

Shabir, G.A. Development and validation of an LC assay for benzo[f]quinoline-5,6-dione and identification of its impurities by LC-MS.J. Liq. Chromatogr. Relat. Technol . 2008, 31(3), 428–442.

Shabir, G.A*., Hamid, A., Arain, S.A. Development and validation of an HPLC method for the determination of 2-(4-isobutylphenyl) propionic acid and 4-isobutylacetophenone in a gel formulation. J. Liq. Chromatogr. Relat. Technol. 2007, 30(19), 2851–2862.

Shabir, G.A. Method development and validation of preservatives determinations (benzyl alcohol, ethylene glycol monophenyl ether, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate and butyl hydroxybenzoate) using HPLC. J. Liq. Chromatogr. Relat. Technol. 2007, 30(13), 1951-1962.

Shabir, G.A*., Arain, S. A. Method development and validation of 9α-fluoro-16β-methyl-prednisolone-17-valerate by HPLC.J. Liq. Chromatogr. Relat. Technol. 2007, 30(13), 1923-1932.

Shabir, G.A. Determination of a novel assay for pregn-4-ene-3,20-dione in a gel formulation using high-performance liquid chromatography. J. Liq. Chromatogr. Relat. Technol. 2007, 30(12), 1763 – 1775.

Shabir, G.A*., Lough, J.W., Arain, S. A., Bradshaw, T.K. Evaluation and application of best practice in analytical method validation. J. Liq. Chromatogr. Relat. Technol. 2007, 30 (3), 311-333. Top-Cited Article from 2007-2011 © 2010 Thomson Reuters, 2009 Journal Citation Reports®

Shabir, G.A. Method development and validation for the HPLC assay of hydrolysed gelatine. J. Li.q. Chromatogr. Relat. Technol. 2006, 29 (9), 1257-1270.

Shabir, G.A*., Lough, W.J., Arain, S.A., Shar, G.Q. Method development and validation of preservatives (phenylformic acid, 2,4-hexadienoic acid, methyl 4-hydroxybenzoate, and propyl 4-hydroxybenzoate) by HPLC.J. Liq. Chromatogr. Relat. Technol. 2006, 29 (9), 1223-1233.

Separation Science and Technology, Publisher: Taylor & Francis, Inc., Philadelphia, USA

Shabir, G.A. Systematic strategies in high-performance liquid chromatography method development and validation. Sep. Sci. Technol. 2010, 45(5), 670–680

Journal of Analytical Chemistry, Publisher: Springer-Verlag, Moscow, Russia

Shabir, G.A. Determination of guaiphenesin and sodium benzoate in liqufruta garlic cough medicine by HPLC. J. Anal. Chem. 2011, 66(10), 963–968.

Indian Journal of Pharmaceutical Sciences, Publisher: Medknow Publications and Media Pvt. Ltd. Mumbai, India

Shabir, G.A*., Bradshaw, T.K. Determination of 1,7,7-Trimethyl-bicyclo(2,2,1)heptan-2-one in a cream pharmaceutical formulation by reversed-phase liquid chromatography. Indian J. Pharm. Sci. 2010, 72 (6), 809-814.

Shabir, G.A. A new validated HPLC method for the simultaneous determination of 2-phenoxyethanol, methylparaben, ethylparaben and propylparaben in a pharmaceutical gel. Indian J. Pharm. Sci., 2010, 72 (4): 421-425.

Shabir, G.A. Development and validation of a reversed-phase HPLC method for the determination of hydroxybenzene in a cream formulation. Indian J. Pharm. Sci., 2010, 72 (3) 307-311.

Shabir, G.A*., Bradshaw, T.K., Shar, G.Q, Arain, S.A. Development and validation of a RPLC method for the determination of 2-phenoxyethanol in senselle lubricant formulation. Indian J. Pharm. Sci., 2010, 72 (3): 312-317.

Turkish Journal of Pharmaceutical Sciences, Publisher: The Turkish Pharmacists' Association, Academy of Pharmacy, Çankaya-Ankara, Turkey

Shabir, G.A*., Bradshaw, T.K. Determination of the spermicides nonoxynol-9 in a gel pharmaceutical formulation by RPLC. Turk. J. Pharm. Sci. 2011, 8 (1), 43-52.

Shabir, G.A*., Bradshaw, T.K. Development and validation of a liquid chromatography method for the determination of methyl salicylate in a medicated cream formulation. Turk. J. Pharm. Sci. 2011, 8 (2), 117-126.

Shabir, G A. Evaluation of USP basket and paddle dissolution methods using different generic atenolol tablets. Turk. J. Pharm. Sci. 2011, 8(3), 253-260.

Journal of Pharmaceutical & Biomedical Analysis, Publisher: Elsevier Science, Amsterdam

Shabir, G.A. Method development and validation for the GC-FID assay of p-cymene in tea tree oil formulation. J. Pharma. Biomed. Anal. 2005, 39(3-4), 681-684.

Shabir, G.A. Determination of combined p-hydroxy benzoic acid preservatives in a liquid pharmaceutical formulation and assay by HPLC. J. Pharma. Biomed. Anal. 2004, 34 (1), 207-213.

Shabir, G.A., Forrow, N.J. Validation of a reversed-phase HPLC method for 1,10-phenanthroline-5,6-dione and analysis of its impurities by HPLC-MS. J. Pharma. Biomed. Anal. 2003, 33, 219-230.

Journal of Chromatographic Science, Publisher: Tinsley Preston, Preston Publications: A Division of Preston Industries, Inc. Niles, IL, USA

Shabir, G.A. Development and Validation of a Liquid Chromatography Mass Spectrometry Method for the Determination of 4,5-Diazafluoren-9-one. J. Chromatogr. Sci. 2008, 46(7), 643-648.

Shabir, G.A*., Forrow, N. J. Development and validation of a HPLC method for 4,7-phenanthroline-5,6-dione and identification of its impurities by HPLC-MS/APCI. J. Chromatogr. Sci. 2005, 43(4), 207-212.

Shabir, G.A. Determination of 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide in a gel pharmaceutical formulation by high-performance liquid chromatography. J. Chromatogr. Sci. 2004, 42(5), 280-283.

Journal of Chromatography A, Publisher: Elsevier Science, Amsterdam

Shabir, G.A. Validation of HPLC methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the U.S. Food and Drug Administration, the U.S. Pharmacopoeia and the International Conference on Harmonization. J. Chromatogr. A. 2003, 987(1-2), 57-66. Received Top Cited Author Status (2002 – 2020) Elsevier Award. This paper is in theTop-50 most cited articles

Journal of Validation Technology, Publisher: Institute of Validation technology, Advanstar Communications, California, USA

Shabir, G.A. Step-by-step analytical methods and protocol in the quality system compliance industry. J. Validation Technol. 2004, 10(4), 314-324.

Shabir, G. A. A practical approach to validation of HPLC methods under current good manufacturing practices. J. Validation Technol. 2004, 10(3), 210-218.

Pharmaceutical Technology Europe, Publisher: Advanstar Communications, Woodland Hills, California, USA

Shabir, G.A. HPLC method development and validation for pharmaceutical analysis. Pharm. Technology Europe. 2004, 16(3), 37-49.

American Pharmaceutical Review, Publisher: Russell Publishing L.L.C., Indianapolis, USA

Shabir G.A. A 20 Year Retrospective: The Pharmaceutical Industry Then and Now. Looking ahead what does the industry need to do to address growing concerns over cost, time to market, government/regulatory scrutiny, and quality/safety of products? 15 Oct 2018. https://www.americanpharmaceuticalreview.com/Featured-Articles/354573-A-20-Year-Retrospective-The-Pharmaceutical-Industry-Then-and-Now/

Shabir, G.A. Equipment Cleaning Validation: Developing an HPLC Method to Determine Contamination Residues on Equipment Surfaces. American Pharmaceutical Review, 2008, 11(4), 16-22.

Shabir, G. A. Review of Pharmaceutical Product Stability, Packaging and the ICH Guidelines. American Pharmaceutical Review, 2008, 11(1), 139-141.

Shabir, G.A*., Arain, S. A. The role of R&D in stability of drug development. American Pharmaceutical Review, 2004, 7(5), 32-38, 47.

Shabir, G.A*., Arain, S. A. The role of cleanrooms in sterile pharmaceutical manufacture and sterility testing. American Pharmaceutical Review, 2004, 7/3, 70-75

American Pharmaceutical Outsourcing (Journal of Pharmaceutical & Biopharmaceutical Contract Services) Publisher: Russell Publishing L.L.C., Indianapolis, USA

Shabir, G.A. Formulation Development Roundtable: Small and large pharma decide to outsource formulation development for different reasons. Discuss some of these contrasting key drivers, Pharmaceutical Outsourcing, January/February vol. 15, issue 1 (2014).

Shabir, G.A. Higher management role and importance of Quality Assurance in the Pharmaceutical Industry, American Pharmaceutical Outsourcing, September/October 2013, 14(5), 42-46.

Shabir, G.A. Current trend in technology transfer process in the pharmaceutical industry. American Pharmaceutical Outsourcing, 2006, 7(2), 24-34.

Shabir, G.A. Stability and shelf life testing for pharmaceutical products. American Pharmaceutical Outsourcing, 2003, 4(5), 34-41.

International Journal of Manufacturing, Publisher: The Institute of Manufacturing, Kenilworth, Warwickshire, UK

Shabir, G. A. Experimental design and optimisation in research development. Int. J. Manufacturing. 2005, 3(7), 19-28.

Shabir, G.A. Leadership in industry. Int. J. Manufacturing. 2003, 3(5), 3-7.

Shabir, G.A. Current good manufacturing practice (CGMP). Int. J. Manufacturing. 1999, 3(1), 14-19.

Shabir, G.A. Higher management role and quality assurance. Award-winning article, Int. J. Manufacturing. 1998, 2(10), 7-11.

International Journal of Manufacturing Management, Publisher: The Institute of Manufacturing, Kenilworth, Warwickshire, UK

Shabir, G.A. Outsourcing of the quality control operations in the pharmaceutical manufacturing industry. Int. J. Manufacturing Management. 2005, 3(7), 12-16.

Shabir, G.A. Effective batch documentation for pharmaceutical manufacturing process and implementation of a quality system – A user’s perspective. Int. J. Manufacturing Management. 2004, 3(6), 19-25.

Shabir, G.A. An effective presentation: How to carry the day with confidence and success. Int. J. Manufacturing Management. 2003, 3(5), 18-25.

Shabir, G. A. Effective meetings. Int. J. Manufacturing Management. 2002, 3(4), 23-31.

Shabir, G.A. Performance management: The user’s practical guide. Int. J. Manufacturing Management. 2001, 3(3), 8-14.

Shabir, G.A. Technology transfer within the pharmaceutical industry. Int. J. Manufacturing Management. 2000, 3(2), 20-24.

Shabir, G.A. Management development: A guide for managers. Int. J. Manufacturing Management. 1999, 3(1), 16-20.

International Journal of Professional Business & Technical Management, Publisher: The Institute of Manufacturing, Kenilworth, Warwickshire, UK

Shabir, G.A. Quality control, quality assurance and quality management in pharmaceutical manufacturing. Int. J. Professional Business & Technical Management. 2004, 2(3), 15-20.

Shabir, G.A. Specifications and setting acceptance criteria for validation studies. Int. J. Professional Business & Technical Management. 2004, 2(4), 9-13.

Shabir, G.A. Introduction to good laboratory practices and current good manufacturing practices. Int. J. Professional Business & Technical Management. 2000, 1(2), 7-12.

Journal of the Academy of Multi-Skills, Publisher: The Institute of Manufacturing, Kenilworth, Warwickshire, UK

Shabir, G.A. Understand process validation and installation, operational and performance qualifications. J. Academy of Multi-Skills. 2001, 2(2), 10-17.

Shabir, G.A. Generic medicines and dissolution testing. The Specialist (Int.). 2000, 5(9), 30-33.

Conference Presentations & Invited Lectures

Invited Lecturer, Analytical method development and validation, Sunderland Pharmacy School, University of Sunderland, Sunderland, UK, 18 March 2011.

Oral presentation, Practical guidelines on analytical method development and validation in the compliance industry, Excellence in Physical Chemistry, University of Peshawar, First National Conference On Physical & Environmental Chemistry (PEC-2010), National Centre, 27th-29th September 2010

Poster presentation, Development and validation of a HPLC method for the analysis of 1,7,7-trimethyl-bicyclo(2,2,1)heptan-2-one. 42 IUPAC Congress: Chemistry Solutions, 2-7 August 2009, Glasgow.

Poster presentation, Development and validation of a HPLC method for the analysis of nonylphenoxy-polyethylleneoxy-ethanol. RSC 42 IUPAC Congress: Chemistry Solutions, 2-7 August 2009, Glasgow.

Poster presentation, Practical guideline on HPLC method development and validation in the pharmaceutical industry. RSC 42 IUPAC Congress: Chemistry Solutions, 2-7 August 2009, Glasgow.

Poster presentation, Determination of 11b,17a, 21-trihydroxypregn-4-ene-3,20-dione residues on manufacturing equipment surfaces using HPLC. RSC 42 IUPAC Congress: Chemistry Solutions, 2-7 August 2009, Glasgow.

Invited speaker, HPLC Method Validation - Best Practices for Regulatory Compliance in the Pharmaceutical Industry. Symposium on Impact of Separation Science on Pharmaceutical R&D - and Beyond, organised by the Chromatographic Society, Stadium of Light, Sunderland UK, 15 November 2007

Invited lecturer, Validation of Analytical Methods. Student’s seminar, University of Sunderland, UK, 08 November 2005.

Poster presentation, Development and validation of a HPLC method for nicotinamide adenine dinucleotide and its application to the determination of stability in alkaline solution. 25th International Symposium on Chromatography, October 4 - 8, 2004, Paris, France. Abstracts Section: Bio-analytical No. 11, 2004, p.119

Invited speaker, A practical approach to validation of HPLC methods in pharmaceutical analysis under current good manufacturing practices. 27th International symposium on high performance liquid phase separations and related techniques, 15- 19 June Nice, France, Abstract Section: Validation Methods 1, 2003, p. 150.

Invited speaker, Validation of HPLC methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the US food and drug administration, the US pharmacopoeia and the international conference on harmonization. 26th International Symposium on High Performance Liquid Phase Separations and Related Techniques, June 2-7, 2002, McGill University, Montreal, Canada. Abstract 577, 2002, p. 144.

Organised and Chaired, international conference on“Molecular Imprints in Separation and Analysis”, The Society of Chemical Industry, International Headquarters, London, UK, 17 April 2002.

Invited speaker, Validation of Analytical Procedures. PhD Students Research Meeting, Separation Sciences and Technology of Society of Chemical Industry, University of Bradford, UK, 16 June 1999.

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