SIMPLE AND FAST RP-HPLC METHOD FOR THE DETERMINATION OF PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE, ATROPINE, AND HOMATROPINE AS RESIDUALS IN CLEANING VALIDATION OF INDUSTRIAL PHARMACEUTICAL EQUIPMENT

REFERENCES

• Cleaning Validation December 2008 Health Sciences Authority–Health Products Regulation Group, Singapore. GUIDE-MQA-008–007. (http://ebookbrowse.com/guide-mqa-008-007-pdf-d373351179)
   Google Scholar
• U.S. Food and Drug Administration (FDA). Guide to Inspections of Validation of Cleaning Processes, July 1993. (http://www.fda.gov/ICECI/Inspections/InspectionGuides/UCM074922.htm).
   Google Scholar
• Sharma , P. P. How to Practice GMPs, A Plan for Total Quality Control, , 2nd ed., Vandana Publication : New Delhi , 1995; pp 302–314.
   Google Scholar
• Dhoka , M. V. ; Dumbre , S. C. ; Sandage , S. J. Spectrophotometric Method for the Determination of Cefpodoxime Proxitil Residue in Swab Samples . Indian Drugs 2009 , 46 ( 9 ), 702 – 707 .
   Google Scholar
• Berry , I. R. ; Nash , R. A. Pharmaceutical Process Validation, , 2nd ed. , Marcel Dekker : New York , 1993 ; 57 , pp 319 – 349 .
   Google Scholar
• Shifflet , M. J. ; Shapiro , M. Development of Analytical Methods to Accurately and Precisely Determine Residual Active Pharmaceutical Ingredients and Cleaning Agents on Pharmaceutical Surfaces . Am. Pharm. Rev. 2002 , 4 , 35 – 39 .
   Google Scholar
• Chudzik , G. M. General Guide to Recovery Studies Using Swab Sampling Methods for Cleaning Validation . J. Validation Technol. 1998 , 5 ( 1 ), 77 – 81 .
   Google Scholar
• Code of Federal Regulations, Title 21: Part 211.67; Food and Drugs General Services Administration: Washington DC, April 1973 .
   Google Scholar
• Pharmaceutical Inspection Convention. Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation, PI 006–2, 17–22, 2004 .
   Google Scholar
• Sajid , S. S. ; Araynea , M. S. ; Sultana , N. Validation of Cleaning of Pharmaceutical Manufacturing Equipment Illustrated by Determination of Cephradine Residues . Anal. Methods 2010 , 2 , 397 – 401 .
   Web of Science ®Google Scholar
• Madhura , V. D. ; Pravin , D. V. ; Pande , A. V. ; Aseem , A. A. Development and Validation of Analytical Method for Estimation of Cefixime in Swab Samples . Int. J. ChemTech Res. 2010 , 2 ( 4 ), 1918 – 1923 .
   Google Scholar
• Katona , Z. ; Vincze , L. ; Vegh , Z. ; Trompler , A. ; Ferenczi Fodor , K. Cleaning validation procedure eased by using over pressured layer chromatography . J. Pharm. Biomed. Anal. 2000 , 22 ( 2 ), 349 – 353 .
   PubMed Web of Science ®Google Scholar
• Urbas , A. A. ; Lodder , R. A. In situ Spectroscopic Cleaning Validation, NIR . Pharmaceutical Validation, NIR News 2003 , 14 ( 2 ), 8 – 10 .
   Google Scholar
• Fourman , G. L. ; Mullen , M. V. Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations . Pharm Tech. 1993 , 17 ( 4 ), 54 – 60 .
   Google Scholar
• Kirsch , R. B. Validation of Analytical Methods Used in Pharmaceutical Cleaning Assessment and Validation . Pharm. Tech. Anal. Valid. 1998 , 22 ( 2 ), 40 – 46 .
   Google Scholar
• Lakshmana , S. ; Prabu , T. N. ; Suriyaprakash , K. Cleaning Validation and its importance in Pharmaceutical Industry . Pharma Times 2010 , 42 ( 7 ), 21 – 25 .
   Google Scholar
• Ghosh , A. ; Dey , S. Overview of Cleaning Validation in Pharmaceutical Industry . Int. J. Pharm. Qual. Assur. 2010 , 2 ( 2 ), 26 – 30 .
   Google Scholar
• Turan , J. ; Matejek , S. ; Potuzak , M. Determination of Organic Bases in Infusion Preparations and Eye Drops . Farm. Obz 1989 , 58 ( 12 ), 551 – 555 .
   Google Scholar
• Akopyan , O. A. ; Popova , V. I. ; Shevchuk , N. M. Analysis of Eye Lotions Containing Atropine sulfate and Homatropine Hydrobromide . Farm-ZH (Kiev) 1991 , 2 , 80 – 82 .
   Google Scholar
• Leung , C. P. ; Wong , K. C.C. Determination of Homatropine Hydrobromide in Eye Drops by Second-Order Derivate Spectroscopy . J. Pharm. Biomed. Anal. 1991 , 9 ( 2 ), 195 – 198 .
   PubMed Web of Science ®Google Scholar
• Lau , O. W. High Performance Liquid Chromatographic determination of Atropine and Atropine-Like alkaloids in pharmaceutical preparations with indirect conductimetric detection . J. Chromatogr. A 1997 , 766 ( 1–2 ), 270 – 276 .
   Web of Science ®Google Scholar
• Cerhan , T. ; Kartal , M. ; Altun , M. L. ; Tülemis , F. ; Cerheroglu , S. LC Determination of Atropine sulfate and Scopolamine Hydrobromide in Pharmaceuticals . J. Pharm. Biomed. Anal. 2001 , 25 ( 3–4 ), 399 – 406 .
   PubMed Web of Science ®Google Scholar
• Stoeckigt , J. ; Sheludkoa , Y. ; Ungerc , M. ; Gerasimenkoa , I. ; Warzecha , H. ; Stöckigt , D. High-Performance Liquid-Chromatographic, Capillary Electrophoretic and Capillary Electrophoretic-Electrospray Ionization Mass Spectrometric Analysis of Selected Alkaloid Groups . J. Chromatogr. A 2002 , 967 , 85 – 113 .
   PubMed Web of Science ®Google Scholar
• Kirchhoff , C. ; Bitar , Y. ; Ebel , S. ; Holzbrabe , U. Analysis of Atropine, Its Degradation Products and Related Substances of Natural Origin by Means of Reversed Phase High Performance Liquid Chromatography . J. Chromatogr. A 2004 , 1046 ( 1–2 ), 115 – 120 .
   PubMed Web of Science ®Google Scholar
• Steenkamp , P. A. ; Harding , N. M. ; van Heerden , F. R. ; van Wyk , B. E. Fatal Datura Poisoning. Identification of Atropine and Scopolamine by High-Performance Liquid-Chromatographic/Photodiode Array/Mass Spectrometry . Foren. Sci. Int. 2004 , 145 ( 1 ), 31 – 39 .
   PubMed Web of Science ®Google Scholar
• Singh , A. ; Sharma , P. K. ; Kumar , N. ; Dudhe , R. Atropine Sulfate in General and GMP Regulation . Int. J. PharmTech Res. 2010 , 2 ( 3 ), 1985 – 1994 .
   Google Scholar
• Cheng , M. H. ; Huang , W. V. ; Llpsey , A. I. Simultaneous Liquid-Chromatographic Determination of Prednisone and Prednisolone in Plasma. Clin. Chem. 1988, 34 (9), 1897–1899.
   PubMed Web of Science ®Google Scholar
• Huber , F. ; Wiedemann , M. ; Heinrich , G. ; Salama , Z. ; Jaeger , H. Development of a High Performance Liquid Chromatography Method for the Simultaneous Measurement of Prednisone and Prednisolone . Arzneimittelforschung 1990 , 40 ( 8 ), 926 – 931 .
   PubMed Web of Science ®Google Scholar
• Bachman , W. J. ; Gambertoglio , J. G. A Stability Indicating HPLC Assay for Prednisolone Sodium Phosphate in Implantable Infusion Pump . Anal. Lett. 1990 , 23 ( 5 ), 893 – 900 .
   Web of Science ®Google Scholar
• Majid , O. ; Akhlaghi , F. ; Lee , T. ; Holt , D. W. ; Trull , A. Simultaneous Determination of Plasma Prednisolone, Prednisone, and Cortisol Levels by High-Performance Liquid Chromatography . Ther. Drug Monit. 2001 , 23 ( 2 ), 163 – 168 .
   PubMed Web of Science ®Google Scholar
• Ku , Y. R. ; Liu , Y. C. ; Lin , J. H. Solid-Phase Extraction and High-performance Liquid Chromatographic Analysis of Prednisone Adulterated in a Foreign Herbal Medicine . J. Food Drug Anal. 2001 , 9 ( 3 ), 150 – 152 .
   Web of Science ®Google Scholar
• Ali , M. S. ; Ghori , M. ; Saeed , A. Simultaneous Determination of Ofloxacin, Tetrahydrozoline, Hydrochloride, and Prednisolone Acetate by High-Performance Liquid-Chromatographic . J. Chromatogr. Sci. LA 2002 , 40 ( 8 ), 429 – 433 .
   PubMed Web of Science ®Google Scholar
• Cho , C. Y. ; Shin , B. S. Sensitive Analysis of Prednisolone and Prednisone in Human Plasma by Reversed-Phase High-Performance liquid-Chromatographic with Ultraviolet Detection . Anal. Lett. 2003 , 36 ( 8 ), 1573 – 1585 .
   Web of Science ®Google Scholar
• Pérez Arroy , J. ; Lemus Gallego , J. M. Determination of Prednisolone, Naphazoline and Phenylephrine in Local Pharmaceutical Preparations by Micellar Electrokinetic Chromatography . J. Sep. Sci. 2003 , 26 , 947 – 995 .
   Web of Science ®Google Scholar
• B´Hymer , C. Evaluation of an HPLC Test for Impurities in the Corticosteroid, 11 beta, 21-dihydroxy-pregna-1,4-dione-3,20-dione(17a,16a-d) 2´-methyloxazoline-21-acetate . J. Liq. Chromatogr. Rel. Tech. 2004 , 27 ( 12 ), 1915 – 1924 .
   Google Scholar
• Parris , N. A. A Practical Manual of HPLC Methods , Journal of Chromatography. Library 27 ; Elsevier Publishing : Amsterdam , 1984 .
   Google Scholar
• Snyder , L. R. ; Kirkland , J. J. ; Glajch , J. L. Practical HPLC Method Development , John Wiley & Sons : Chichester-New York-Weinheim-Brisbane-Singapore-Toronto , 1997 .
   Google Scholar
• Clarke's 2004 . Analysis of Drugs and Poisons , Pharmaceutical Press : Great Britain , 2004 .
   Google Scholar
• Meyer , R. V. Practical High-performance Liquid Chromatography, , 4th ed. , John Wiley & Sons : Chichester-New York-Weinheim-Brisbane-Singapore-Toronto , 2004 .
   Google Scholar