Development and validation of stability-indicating RP-HPLC method for simultaneous estimation of clomiphene citrate and co-enzyme Q10 in bulk and pharmaceutical dose.

IF 1.3 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of chromatographic science Pub Date : 2026-04-30 DOI:10.1093/chromsci/bmag013

Malavika Thiruvenkatakumar, Hariprasad Ranganathan, Habibur Rahman S M

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引用次数: 0

Abstract

Clomiphene citrate (CLO) and co-enzyme Q10 (Q10) are "ovulatory stimulants" used to treat female infertility and CLO-resistant Polycystic Ovary Syndrome (PCOS). The study aimed to create a unique and well-validated stability-indicating RP-HPLC method for quantifying CLO and Q10 in bulk and tablet formulation, supported by UV analysis. The λ max values of CLO and Q10 were determined at 293 nm and 273 nm, respectively. The chromatographic separation was achieved on a Waters XBridge phenyl 5 μm column (4.6 × 250 mm) using an acetonitrile: tetrahydrofuran (80:20 v/v) with 0.5% triethylamine as a mobile phase at a flow rate of 0.5 mL/min with photodiode array detector at 279 nm (isobestic point). Resveratrol (RES) served as an internal standard (ISTD), with retention durations of 6.504, 9.319 and 5.831 minutes for CLO, Q10 and RES, respectively. Calibration curves were linear (R2 = 0.9987 for CLO and 0.9993 for Q10) and %RSD values for all validation parameters were below 2%, confirming precision and accurate. Forced degradation studies through various stress conditions, assessed the method's stability-indicating nature by exhibiting clear separation of degradation products from the analytes and degradation levels within ICH limits (≤ 20%). The validated method was found to be reliable, specific, and applicable for routine analysis in quality control.

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同时测定枸橼酸克罗米芬和辅酶Q10原料药剂量的反相高效液相色谱法的建立与验证。

枸橼酸克罗米芬（CLO）和辅酶Q10 （Q10）是“促排卵剂”，用于治疗女性不孕症和抗CLO多囊卵巢综合征（PCOS）。本研究旨在建立一种独特且经过验证的稳定性指示的反相高效液相色谱（RP-HPLC）方法，用于定量散装和片剂中辅酶Q10和辅酶Q10。CLO和Q10的λ max分别在293 nm和273 nm处测定。采用Waters XBridge苯基5 μm色谱柱（4.6 × 250 mm），以乙腈：四氢呋喃（80:20 v/v）为流动相，0.5%三乙胺为流动相，流速为0.5 mL/min，光电二极管阵列检测器在279 nm（等致点）处进行色谱分离。白藜芦醇（RES）作为内标（ISTD）， CLO、Q10和RES的滞留时间分别为6.504、9.319和5.831 min。校正曲线呈线性（R2 = 0.9987， Q10的R2 = 0.9993），所有验证参数的%RSD值均小于2%，证实了精密度和准确性。通过各种应力条件下的强制降解研究，通过显示降解产物与分析物的清晰分离以及在ICH限制内的降解水平（≤20%）来评估该方法的稳定性。结果表明，该方法可靠、专属性强，可用于质量控制中的常规分析。

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来源期刊

Journal of chromatographic science 化学-分析化学

CiteScore

2.90

自引率

7.70%

发文量

审稿时长

5.6 months

期刊介绍： The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.