A validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage forms
A new method for the simultaneous determination of paracetamol (PR) and lornoxicam (LR) has been developed by reversed phase HPLC from the combination drug product. The separation achieved on C18 column using acetonitrile and 0.02 M potassium dihydrogen phosphate was in the ratio of 35:6...
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| Format: | Article |
| Language: | English |
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Association of the Chemical Engineers of Serbia
2014-01-01
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| Series: | Chemical Industry and Chemical Engineering Quarterly |
| Subjects: | |
| Online Access: | http://www.doiserbia.nb.rs/img/doi/1451-9372/2014/1451-93721200106K.pdf |
| _version_ | 1819155823412117504 |
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| author | Karunakaran Kulandaivelu Navaneethan Gurusamy Pitchaimuthu Kuppanagounder Elango |
| author_facet | Karunakaran Kulandaivelu Navaneethan Gurusamy Pitchaimuthu Kuppanagounder Elango |
| author_sort | Karunakaran Kulandaivelu |
| collection | DOAJ |
| description | A new method for the simultaneous determination of paracetamol (PR) and
lornoxicam (LR) has been developed by reversed phase HPLC from the
combination drug product. The separation achieved on C18 column using
acetonitrile and 0.02 M potassium dihydrogen phosphate was in the ratio of
35:65 (v/v) as mobile phase at a flow rate of 1.0 mL/min. Both the components
were monitored at a single wavelength at 260 nm and the column temperature
was maintained at 30°C throughout the analysis. A linear response was found
in the concentration range of 125-375 μg/mL for PR and 2-6 μg/mL for LR, with
the correlation coefficient of more than 0.999. Although the tablet contained
a high dose of PR (500 mg) and a low dose of LR (8 mg), the single HPLC
method was developed and the intra as well as inter day precision was
obtained at less than 2% of RSD. The accuracy results obtained were between
98% and 102%. The drug was intentionally degraded under acidic, basic,
peroxide, thermal, and photolytic conditions. The major degradation observed
for both PR and LR under peroxide condition indicated that the drug product
is susceptible to oxidation. The degraded peaks were properly resolved from
PR and LR. Hence, the method is stability indicating. |
| first_indexed | 2024-12-22T15:43:06Z |
| format | Article |
| id | doaj.art-72f4f02f358849f4a9ed1765cc86b554 |
| institution | Directory Open Access Journal |
| issn | 1451-9372 2217-7434 |
| language | English |
| last_indexed | 2024-12-22T15:43:06Z |
| publishDate | 2014-01-01 |
| publisher | Association of the Chemical Engineers of Serbia |
| record_format | Article |
| series | Chemical Industry and Chemical Engineering Quarterly |
| spelling | doaj.art-72f4f02f358849f4a9ed1765cc86b5542022-12-21T18:21:05ZengAssociation of the Chemical Engineers of SerbiaChemical Industry and Chemical Engineering Quarterly1451-93722217-74342014-01-0120110911410.2298/CICEQ120502106K1451-93721200106KA validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage formsKarunakaran Kulandaivelu0Navaneethan Gurusamy1Pitchaimuthu Kuppanagounder Elango2Department of Chemistry, Sona College of Technology (Anna University), Salem, IndiaDepartment of Chemistry, Sona College of Technology (Anna University), Salem, IndiaDepartment of Chemistry, Gandhigram Rural Institute (Deemed University), Gandhigram, IndiaA new method for the simultaneous determination of paracetamol (PR) and lornoxicam (LR) has been developed by reversed phase HPLC from the combination drug product. The separation achieved on C18 column using acetonitrile and 0.02 M potassium dihydrogen phosphate was in the ratio of 35:65 (v/v) as mobile phase at a flow rate of 1.0 mL/min. Both the components were monitored at a single wavelength at 260 nm and the column temperature was maintained at 30°C throughout the analysis. A linear response was found in the concentration range of 125-375 μg/mL for PR and 2-6 μg/mL for LR, with the correlation coefficient of more than 0.999. Although the tablet contained a high dose of PR (500 mg) and a low dose of LR (8 mg), the single HPLC method was developed and the intra as well as inter day precision was obtained at less than 2% of RSD. The accuracy results obtained were between 98% and 102%. The drug was intentionally degraded under acidic, basic, peroxide, thermal, and photolytic conditions. The major degradation observed for both PR and LR under peroxide condition indicated that the drug product is susceptible to oxidation. The degraded peaks were properly resolved from PR and LR. Hence, the method is stability indicating.http://www.doiserbia.nb.rs/img/doi/1451-9372/2014/1451-93721200106K.pdfRP-HPLCparacetamollornoxicamstability indicatingforced degradationvalidation |
| spellingShingle | Karunakaran Kulandaivelu Navaneethan Gurusamy Pitchaimuthu Kuppanagounder Elango A validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage forms Chemical Industry and Chemical Engineering Quarterly RP-HPLC paracetamol lornoxicam stability indicating forced degradation validation |
| title | A validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage forms |
| title_full | A validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage forms |
| title_fullStr | A validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage forms |
| title_full_unstemmed | A validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage forms |
| title_short | A validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage forms |
| title_sort | validated stability indicating rp hplc method for paracetamol and lornoxicam application to pharmaceutical dosage forms |
| topic | RP-HPLC paracetamol lornoxicam stability indicating forced degradation validation |
| url | http://www.doiserbia.nb.rs/img/doi/1451-9372/2014/1451-93721200106K.pdf |
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