Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum

A reverse phase stability indicating HPLC method for simultaneous determination of two antispasmodic drugs in pharmaceutical parenteral dosage forms (injectable) and in serum has been developed and validated. Mobile phase ingredients consist of Acetonitrile : buffer : sulfuric acid 0.1 M (50 : 50 : ...

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Main Authors: Najmul Hasan, Mathurot Chaiharn, Sauleha Khan, Hira Khalid, Nawab Sher, Farhan Ahmed Siddiqui, Muhammad Zain Siddiqui
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:Journal of Analytical Methods in Chemistry
Online Access:http://dx.doi.org/10.1155/2013/297285
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author Najmul Hasan
Mathurot Chaiharn
Sauleha Khan
Hira Khalid
Nawab Sher
Farhan Ahmed Siddiqui
Muhammad Zain Siddiqui
author_facet Najmul Hasan
Mathurot Chaiharn
Sauleha Khan
Hira Khalid
Nawab Sher
Farhan Ahmed Siddiqui
Muhammad Zain Siddiqui
author_sort Najmul Hasan
collection DOAJ
description A reverse phase stability indicating HPLC method for simultaneous determination of two antispasmodic drugs in pharmaceutical parenteral dosage forms (injectable) and in serum has been developed and validated. Mobile phase ingredients consist of Acetonitrile : buffer : sulfuric acid 0.1 M (50 : 50 : 0.3 v/v/v), at flow rate 1.0 mL/min using a Hibar μBondapak ODS C18 column monitored at dual wavelength of 266 nm and 205 nm for phloroglucinol and trimethylphloroglucinol, respectively. The drugs were subjected to stress conditions of hydrolysis (oxidation, base, acid, and thermal degradation). Oxidation degraded the molecule drastically while there was not so much significant effect of other stress conditions. The calibration curve was linear with a correlation coefficient of 0.9999 and 0.9992 for PG and TMP, respectively. The drug recoveries fall in the range of 98.56% and 101.24% with 10 pg/mL and 33 pg/mL limit of detection and limit of quantification for both phloroglucinol and trimethylphloroglucinol. The method was validated in accordance with ICH guidelines and was applied successfully to quantify the amount of trimethylphloroglucinol and phloroglucinol in bulk, injectable form and physiological fluid. Forced degradation studies proved the stability indicating abilities of the method.
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institution Kabale University
issn 2090-8865
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language English
publishDate 2013-01-01
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series Journal of Analytical Methods in Chemistry
spelling doaj-art-60c916b44c984b17b05a4b1d04f2f1392025-02-03T05:44:43ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732013-01-01201310.1155/2013/297285297285Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human SerumNajmul Hasan0Mathurot Chaiharn1Sauleha Khan2Hira Khalid3Nawab Sher4Farhan Ahmed Siddiqui5Muhammad Zain Siddiqui6Department of Microbiology, Faculty of Science, University of Karachi, Karachi 75270, PakistanDivision of Biotechnology, Faculty of Science, Maejo University, Chiang Mai 50290, ThailandDepartment of Chemistry, Faculty of Science, University of Karachi, Karachi 75270, PakistanDepartment of Chemistry, Government College University, Lahore 54000, PakistanDepartment of Chemistry, Faculty of Science, University of Karachi, Karachi 75270, PakistanFaculty of Pharmacy, Federal Urdu University of Science & Technology, Karachi 75300, PakistanDepartment of Chemistry, Faculty of Science, Federal Urdu University of Science & Technology, Karachi 75300, PakistanA reverse phase stability indicating HPLC method for simultaneous determination of two antispasmodic drugs in pharmaceutical parenteral dosage forms (injectable) and in serum has been developed and validated. Mobile phase ingredients consist of Acetonitrile : buffer : sulfuric acid 0.1 M (50 : 50 : 0.3 v/v/v), at flow rate 1.0 mL/min using a Hibar μBondapak ODS C18 column monitored at dual wavelength of 266 nm and 205 nm for phloroglucinol and trimethylphloroglucinol, respectively. The drugs were subjected to stress conditions of hydrolysis (oxidation, base, acid, and thermal degradation). Oxidation degraded the molecule drastically while there was not so much significant effect of other stress conditions. The calibration curve was linear with a correlation coefficient of 0.9999 and 0.9992 for PG and TMP, respectively. The drug recoveries fall in the range of 98.56% and 101.24% with 10 pg/mL and 33 pg/mL limit of detection and limit of quantification for both phloroglucinol and trimethylphloroglucinol. The method was validated in accordance with ICH guidelines and was applied successfully to quantify the amount of trimethylphloroglucinol and phloroglucinol in bulk, injectable form and physiological fluid. Forced degradation studies proved the stability indicating abilities of the method.http://dx.doi.org/10.1155/2013/297285
spellingShingle Najmul Hasan
Mathurot Chaiharn
Sauleha Khan
Hira Khalid
Nawab Sher
Farhan Ahmed Siddiqui
Muhammad Zain Siddiqui
Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum
Journal of Analytical Methods in Chemistry
title Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum
title_full Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum
title_fullStr Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum
title_full_unstemmed Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum
title_short Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum
title_sort dual wavelength rp hplc method for simultaneous determination of two antispasmodic drugs an application in pharmaceutical and human serum
url http://dx.doi.org/10.1155/2013/297285
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