Validation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage Forms
Background: Naloxegol is a peripherally acting µ-opioid antagonist. Purpose: The aim of the present research was to develop and validate a Reverse Phase High-Performance Liquid Chromatography for quantitative determination of Naloxegol in pharmaceutical dosage forms. Methodology: HPLC syste...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Krupanidhi College of Pharmacy
2021-12-01
|
| Series: | Journal of Pharmaceutical Research |
| Online Access: | https://jopcr.com/articles/validation-of-novel-rp-hplc-method-for-the-estimation-of-naloxegol-in-pharmaceutical-dosage-forms |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849230140202024960 |
|---|---|
| author | A Suneetha G I Priyadarshini V Mounika Ayesha Ameen K Jyothi A Babitha |
| author_facet | A Suneetha G I Priyadarshini V Mounika Ayesha Ameen K Jyothi A Babitha |
| author_sort | A Suneetha |
| collection | DOAJ |
| description | Background: Naloxegol is a peripherally acting µ-opioid antagonist. Purpose: The aim of the present research was to develop and validate a Reverse Phase High-Performance Liquid Chromatography for quantitative determination of Naloxegol in pharmaceutical dosage forms. Methodology: HPLC system used was Shimadzu coupled to a Photodiode Array Detector and was operated in an isocratic mode. Separation was achieved using Inertsil-C18 ODS column having dimensions 250 mm × 4.6 mm, 5 μm and the mobile phase composed of 90 volumes of methanol and 10 volumes of acetonitrile mixture. The flow rate of the mobile phase was 1 mL min−1. Detection wavelength was 250 nm and temperature was 25°C. Findings: The method was validated with regard to linearity, accuracy, precision, selectivity, and robustness in accordance with ICH guidelines. Conclusion: From this study it was concluded that the proposed method is accurate, reproducible and precise. Application: The method was applied successfully for the estimation of Naloxegol in marketed tablet dosage form. Keywords High-Performance Liquid Chromatography, Naloxegol |
| format | Article |
| id | doaj-art-229b3345a53c4fa8bfb618ddc678b5ab |
| institution | Kabale University |
| issn | 0973-7200 2454-8405 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | Krupanidhi College of Pharmacy |
| record_format | Article |
| series | Journal of Pharmaceutical Research |
| spelling | doaj-art-229b3345a53c4fa8bfb618ddc678b5ab2025-08-21T09:34:08ZengKrupanidhi College of PharmacyJournal of Pharmaceutical Research0973-72002454-84052021-12-01204677010.18579/jopcr/v20i4.suneethaValidation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage FormsA SuneethaG I Priyadarshini V MounikaAyesha AmeenK Jyothi A Babitha Background: Naloxegol is a peripherally acting µ-opioid antagonist. Purpose: The aim of the present research was to develop and validate a Reverse Phase High-Performance Liquid Chromatography for quantitative determination of Naloxegol in pharmaceutical dosage forms. Methodology: HPLC system used was Shimadzu coupled to a Photodiode Array Detector and was operated in an isocratic mode. Separation was achieved using Inertsil-C18 ODS column having dimensions 250 mm × 4.6 mm, 5 μm and the mobile phase composed of 90 volumes of methanol and 10 volumes of acetonitrile mixture. The flow rate of the mobile phase was 1 mL min−1. Detection wavelength was 250 nm and temperature was 25°C. Findings: The method was validated with regard to linearity, accuracy, precision, selectivity, and robustness in accordance with ICH guidelines. Conclusion: From this study it was concluded that the proposed method is accurate, reproducible and precise. Application: The method was applied successfully for the estimation of Naloxegol in marketed tablet dosage form. Keywords High-Performance Liquid Chromatography, Naloxegolhttps://jopcr.com/articles/validation-of-novel-rp-hplc-method-for-the-estimation-of-naloxegol-in-pharmaceutical-dosage-forms |
| spellingShingle | A Suneetha G I Priyadarshini V Mounika Ayesha Ameen K Jyothi A Babitha Validation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage Forms Journal of Pharmaceutical Research |
| title | Validation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage Forms |
| title_full | Validation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage Forms |
| title_fullStr | Validation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage Forms |
| title_full_unstemmed | Validation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage Forms |
| title_short | Validation of Novel RP-HPLC Method for the Estimation of Naloxegol in Pharmaceutical Dosage Forms |
| title_sort | validation of novel rp hplc method for the estimation of naloxegol in pharmaceutical dosage forms |
| url | https://jopcr.com/articles/validation-of-novel-rp-hplc-method-for-the-estimation-of-naloxegol-in-pharmaceutical-dosage-forms |
| work_keys_str_mv | AT asuneetha validationofnovelrphplcmethodfortheestimationofnaloxegolinpharmaceuticaldosageforms AT gipriyadarshini validationofnovelrphplcmethodfortheestimationofnaloxegolinpharmaceuticaldosageforms AT vmounika validationofnovelrphplcmethodfortheestimationofnaloxegolinpharmaceuticaldosageforms AT ayeshaameen validationofnovelrphplcmethodfortheestimationofnaloxegolinpharmaceuticaldosageforms AT kjyothi validationofnovelrphplcmethodfortheestimationofnaloxegolinpharmaceuticaldosageforms AT ababitha validationofnovelrphplcmethodfortheestimationofnaloxegolinpharmaceuticaldosageforms |