Stability-indicating RP-HPLC method development and validation for the analysis of doxepin hydrochloride in bulk and pharmaceutical dosage form (Record no. 23429)
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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 | 20250919113004.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250919b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 27226 |
| Author | Rajesh, R. |
| 245 ## - TITLE STATEMENT | |
| Title | Stability-indicating RP-HPLC method development and validation for the analysis of doxepin hydrochloride in bulk and pharmaceutical dosage form |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.16(4) |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Bhopal |
| Name of publisher, distributor, etc. | Innovare Academic Sciences Pvt Ltd |
| Year | 2024 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 27-35p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Objective: A simple, reliable, and rapid RP-HPLC method showing stability has been established to detect Doxepin Hydrochloride (DOX) with its degraded products. The proposed method has been validated for specificity, linearity, system suitability, accuracy, precision, robustness, LOD, and LOQ as per ICH guidelines. All parameters were found to be within the accepted limits, affirming the method's reliability.<br/><br/>Methods: Analysis was conducted using RP-HPLC on a Phenomenex C18 Luna column (250 mm × 4.6 mm id, 5 µm) with a mobile phase comprising methanol, acetonitrile, and buffer (40:30:30, v/v/v) and a flow rate of 0.5 ml/min. The detection was performed with a UV detector set at 254 nm. Diverse methods have been employed to investigate forced degradation studies, including acid-base hydrolysis, photolysis, thermal degradation, and oxidation. These studies were conducted both in bulk and in capsule formulations of DOX.<br/><br/>Results: The retention time (tR) of DOX was 2.92 minutes, and all parameters met acceptable limit values. The response exhibited linearity over a concentration range of 10 to 50 µg/ml (R2 = 0.9974). The percentage of DOX recovered from the pharmaceutical cream dosage form ranged from 97.67% to 101%. Sensitivity levels for the developed method were indicated by limit of detection (LOD) and limit of quantification (LOQ) values of 0.40–0.50 µg/ml. The proposed method was validated according to ICH guidelines.<br/><br/>Conclusion: Hence, a simple, reliable, accurate, and precise HPLC method was developed, proving suitable for the analysis of DOX in both bulk and commercial formulations. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 773 0# - HOST ITEM ENTRY | |
| Place, publisher, and date of publication | Bhopal Innovare Academic Sciences Pvt Ltd |
| International Standard Serial Number | 2656-0097 |
| Title | International journal of pharmacy and pharmaceutical science |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://journals.innovareacademics.in/index.php/ijpps/article/view/50126 |
| Link text | Click here |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 19/09/2025 | 2025-1458 | 19/09/2025 | 19/09/2025 | Articles Abstract Database |