Development, Validation and Application of RP-HPLC Method: Simultaneous Determination of Antihistamine and Preservatives with Paracetamol in Liquid Formulations and Human Serum
In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives i.e. propylparaben, and methylparaben in pharmaceutical dosage f...
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| Published in | The open medicinal chemistry journal Vol. 10; no. 1; pp. 33 - 43 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United Arab Emirates
Bentham Open
31.08.2016
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| Abstract | In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives
i.e.
propylparaben, and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Buffer: Sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min
-1
using a Hibar
®
Lichrosorb
®
C
18
column and monitored at wavelength of 230nm. The averages of absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and Propylparaben respectively. The limit of quantification and limit of detection were in range of 0.3 to 2.7 ng mL
-1
and 0.1 to 0.8 ng mL
-1
respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed while all drugs were found almost stable in the other conditions. The developed method was validated in accordance with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid. |
|---|---|
| AbstractList | In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives
i.e.
propylparaben, and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Buffer: Sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min
-1
using a Hibar
®
Lichrosorb
®
C
18
column and monitored at wavelength of 230nm. The averages of absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and Propylparaben respectively. The limit of quantification and limit of detection were in range of 0.3 to 2.7 ng mL
-1
and 0.1 to 0.8 ng mL
-1
respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed while all drugs were found almost stable in the other conditions. The developed method was validated in accordance with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid. In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives i.e. propylparaben, and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Buffer: Sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min(-1) using a Hibar(®) Lichrosorb(®) C18 column and monitored at wavelength of 230nm. The averages of absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and Propylparaben respectively. The limit of quantification and limit of detection were in range of 0.3 to 2.7 ng mL(-1) and 0.1 to 0.8 ng mL(-1) respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed while all drugs were found almost stable in the other conditions. The developed method was validated in accordance with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid. In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives i.e. propylparaben, and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Buffer: Sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min(-1) using a Hibar(®) Lichrosorb(®) C18 column and monitored at wavelength of 230nm. The averages of absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and Propylparaben respectively. The limit of quantification and limit of detection were in range of 0.3 to 2.7 ng mL(-1) and 0.1 to 0.8 ng mL(-1) respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed while all drugs were found almost stable in the other conditions. The developed method was validated in accordance with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid.In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives i.e. propylparaben, and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Buffer: Sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min(-1) using a Hibar(®) Lichrosorb(®) C18 column and monitored at wavelength of 230nm. The averages of absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and Propylparaben respectively. The limit of quantification and limit of detection were in range of 0.3 to 2.7 ng mL(-1) and 0.1 to 0.8 ng mL(-1) respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed while all drugs were found almost stable in the other conditions. The developed method was validated in accordance with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid. |
| Author | Aziz, Mubashir Mirani, Zulfiqar Ali Hasan, Najmul Toor, Umair Ali Sajjad, Ghulam Sher, Nawab Chaiharn, Mathurot Siddiqui, Farhan Ahmed |
| AuthorAffiliation | 7 Faculty of Pharmacy, Federal Urdu University of Arts, Science & Technology, Karachi 75300, Pakistan 6 Department of Pathobiology, Faculty of Veterinary Sciences, Bahauddin Zakariya University, Multan, Pakistan 5 Department of Chemistry, Faculty of Science, University of Karachi, Karachi 75270, Pakistan 3 Microbiological Analytical Centre, Pakistan Council of Scientific and Industrial Laboratories Complex, Karachi, Pakistan 2 Division of Biotechnology, Faculty of Science, Maejo University, Chiang Mai 50290, Thailand 4 Quality Assurance, Taj Fisheries (Pvt) Ltd, Fish Harbour, West Wharf, Karachi, Pakistan 1 Department of Environmental Sciences and Biotechnology, Hallym University, Chuncheon, Gangwon do 200-702, South Korea |
| AuthorAffiliation_xml | – name: 5 Department of Chemistry, Faculty of Science, University of Karachi, Karachi 75270, Pakistan – name: 3 Microbiological Analytical Centre, Pakistan Council of Scientific and Industrial Laboratories Complex, Karachi, Pakistan – name: 4 Quality Assurance, Taj Fisheries (Pvt) Ltd, Fish Harbour, West Wharf, Karachi, Pakistan – name: 2 Division of Biotechnology, Faculty of Science, Maejo University, Chiang Mai 50290, Thailand – name: 6 Department of Pathobiology, Faculty of Veterinary Sciences, Bahauddin Zakariya University, Multan, Pakistan – name: 1 Department of Environmental Sciences and Biotechnology, Hallym University, Chuncheon, Gangwon do 200-702, South Korea – name: 7 Faculty of Pharmacy, Federal Urdu University of Arts, Science & Technology, Karachi 75300, Pakistan |
| Author_xml | – sequence: 1 givenname: Najmul surname: Hasan fullname: Hasan, Najmul – sequence: 2 givenname: Mathurot surname: Chaiharn fullname: Chaiharn, Mathurot – sequence: 3 givenname: Umair Ali surname: Toor fullname: Toor, Umair Ali – sequence: 4 givenname: Zulfiqar Ali surname: Mirani fullname: Mirani, Zulfiqar Ali – sequence: 5 givenname: Ghulam surname: Sajjad fullname: Sajjad, Ghulam – sequence: 6 givenname: Nawab surname: Sher fullname: Sher, Nawab – sequence: 7 givenname: Mubashir surname: Aziz fullname: Aziz, Mubashir – sequence: 8 givenname: Farhan Ahmed surname: Siddiqui fullname: Siddiqui, Farhan Ahmed |
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| Keywords | RP-HPLC Oral solution Paracetamol Preservatives Cetirizine HCl Paraben |
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| Title | Development, Validation and Application of RP-HPLC Method: Simultaneous Determination of Antihistamine and Preservatives with Paracetamol in Liquid Formulations and Human Serum |
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