Development and validation of reversed-phase high-performance liquid chromatography method for the simultaneous determination of tezacaftor and ivacaftor in bulk and pharmaceutical formulation (Record no. 15659)
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| 000 -LEADER | |
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| fixed length control field | a |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20211221110235.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 211221b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 14905 |
| Author | Dharmamoorthy, G. |
| 245 ## - TITLE STATEMENT | |
| Title | Development and validation of reversed-phase high-performance liquid chromatography method for the simultaneous determination of tezacaftor and ivacaftor in bulk and pharmaceutical formulation |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.15(3), Jul-Sep |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Mandsaur |
| Name of publisher, distributor, etc. | B.R. Nahata Smriti Sansthan |
| Year | 2021 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 298-306p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Objective: The objective of the study was to develop analytical method for the estimation of tezacaftor and ivacaftor<br/>in bulk and its combination dosage form and to validate the method developed according to ICH guidelines.<br/>Materials and Methods: Chromatographic separation was achieved through Ascentis C18 150 × 4.6 mm, 5 m<br/>using 0.1% OPA: acetonitrile (70:30 v/v) mixture used as the mobile phase. The Water ACQUITY Model highperformance<br/>liquid chromatography system with photodiode array detector and EMPOWER version 2.0 software<br/>was monitored at detection wavelength 260 nm with flow rate of 1.0 ml/min and the method was validated as per<br/>ICH guidelines. Results and Discussion: By applying the proposed method, the retention times of tezacaftor and<br/>ivacaftor were found to be 3.0 and 3.6 min, respectively. %RSD of method precision for tezacaftor and ivacaftor<br/>was found to be 0.8 and 0.5, respectively. % recovery was obtained as 99.61% and 99.92% for tezacaftor and<br/>ivacaftor, respectively. Retention times were less so, the method developed was simple and economical and can be<br/>adopted in regular quality control analysis for selected drugs. Conclusion: This method was successfully applied<br/>for the determination of tezacaftor and ivacaftor in their pharmaceutical formulation and hence can be the routine<br/>analysis of these drugs in combined dosage form. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 14906 |
| Co-Author | Chandrasukeerthi, K. |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 14907 |
| Co-Author | M. Kishore Babu |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 14908 |
| Co-Author | M Gurava Reddy |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 6987 |
| Co-Author | Nanda Kumara, K. V. |
| 773 0# - HOST ITEM ENTRY | |
| Place, publisher, and date of publication | Mandsaur B.R. Nahata Smriti Sansthan |
| Title | International journal of green pharmacy |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | http://greenpharmacy.info/index.php/ijgp/article/view/3158 |
| Link text | Full Text |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
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| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 21/12/2021 | 2021-2022477 | 21/12/2021 | 21/12/2021 | Articles Abstract Database |