Advanced stability-indicating RP-HPLC method for the quantification of Lurasidone Hydrochloride in bulk and PLGA based in-situ implant formulation.

IF 1 Q4 PHARMACOLOGY & PHARMACY

Annales pharmaceutiques francaises Pub Date : 2024-10-30 DOI:10.1016/j.pharma.2024.10.008

Bankar Anup Ramprasad, Sundeep Chaurasia, Indu Singh

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引用次数: 0

Abstract

Objectives: The aims of the present investigation was to develop and validate stability-indicating RP-HPLC method for the estimation of Lurasidone hydrochloride (LURA-H) followed by its drug product, LURA-H encapsulated poly-D,L lactic-glycolic acid (PLGA) based in-situ depot forming implant (LURA-H-PLGA-ISI).

Methods: The LURA-H-PLGA-ISI formulation was developed by simple mixing method. According to international conference on harmonization guidelines, RP-HPLC method was developed and validated using Waters 2695 and discovery C18, 5μ, 250×4.6 mm ID column. Force degradation studied were performed by various degradation techniques.

Results: The chromatographic separations of LURA-H as well as LURA-H-PLGA-ISI with good resolutions have been achieved using the mobile phase 0.1% orthophosphoric acid and acetonitrile (50:50). The linearity in the range of 25-150 μg/mL of developed method. LOD and LOQ limits for LURA-H were found to be 0.07µg/mL and 0.22 µg/mL, respectively. The % RSD was found to be <2% showing the precision of developed method. The accuracy of developed method was demonstrated which is close to 100±2%. Little modifications in the chromatographic conditions indicated robustness of the developed method. Further, solution stability of LURA-H and LURA-H-PLGA-ISI was stable at room temperature. Furthermore, force degradation studies demonstrated LURA-H was unaffected and stable under thermal, photodegradation and neutral (hydrolytic) stress conditions. AGREE and GAPI assessment demonstrated the developed method is environmentally sustainable.

Conclusion: The developed method is simple, robust, precise, accurate and sensitive which can be utilized for the regular analysis of LURA-H in quality control laboratories of bulk drug substance and PLGA containing formulations of LURA-H.

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先进的稳定性指示 RP-HPLC 方法，用于定量检测散装和基于 PLGA 的原位植入制剂中的盐酸鲁拉西酮。

研究目的本研究旨在开发并验证用于估算盐酸拉西酮（Lurasidone hydrochloride，LURA-H）及其药物产品--LURA-H包裹聚D,L乳酸-乙醇酸（Poly-D,L lactic-glycolic acid，PLGA）原位去势植入物（LURA-H-PLGA-ISI）的稳定性指示RP-HPLC方法：LURA-H-PLGA-ISI配方是通过简单的混合方法研制而成的。根据国际协调准则，使用 Waters 2695 和 discovery C18、5μ、250×4.6 mm 内径色谱柱建立并验证了 RP-HPLC 方法。采用多种降解技术对其进行了降解研究：使用流动相 0.1%正磷酸和乙腈（50:50）对 LURA-H 和 LURA-H-PLGA-ISI 进行了色谱分离，并获得了良好的分辨率。所开发的方法在 25-150 μg/mL 范围内线性良好。LURA-H 的最低检测限和最低定量限分别为 0.07µg/mL 和 0.22 µg/mL。RSD %为结论：所开发的方法简单、稳健、精确、准确、灵敏，可用于原药和含 PLGA 的 LURA-H 制剂质量控制实验室中 LURA-H 的定期分析。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annales pharmaceutiques francaises PHARMACOLOGY & PHARMACY-

CiteScore

1.70

自引率

7.70%

发文量

期刊介绍： This journal proposes a scientific information validated and indexed to be informed about the last research works in all the domains interesting the pharmacy. The original works, general reviews, the focusing, the brief notes, subjected by the best academics and the professionals, propose a synthetic approach of the last progress accomplished in the concerned sectors. The thematic Sessions and the – life of the Academy – resume the communications which, presented in front of the national Academy of pharmacy, are in the heart of the current events.