A validated RP-HPLC method for the estimation of lapatinib in tablet dosage form using gemcitabine hydrochloride as an internal standard

Kumar, K. Vijay; Nagoji, K. E. V.; Nadh, RV

doi:10.4103/0250-474x.110621

Cited by 16 publications

(7 citation statements)

References 12 publications

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“…Furthermore, previous studies which quantify LPT in the bulk pharmaceutical and tablet dosage form have reported precision RSD% of 0.509 and 0.223%, respectively. However, none of these studies were for simultaneous detection [ 11 – 29 ]. By applying the newly developed method, not only was a more precise analysis obtained, but also the simultaneous assay of two chemotherapeutic agents was provided.…”

Section: Resultsmentioning

confidence: 99%

“…Also in another method, the accuracy of LPT alone was expressed as “recovery” which was reported to be in the range limit of 100 ± 4.1%. In that study, neither RE% nor the % RSD was reported [ 11 ].…”

Section: Resultsmentioning

confidence: 99%

“…These methods are not applicable for the determination of LPT in pharmaceutical dosage forms and need serious modifications. Recently, an HPLC method was reported for the determination of LPT in pharmaceutical dosage forms, but it requires further optimization in terms of precision and accuracy which are the two main parts of method validation [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

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Development and Validation of Rapid RP-HPLC-DAD Analysis Method for Simultaneous Quantitation of Paclitaxel and Lapatinib in Polymeric Micelle Formulation

et al. 2016

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A robust and rapid analysis method was developed and validated for the simultaneous assay of paclitaxel (PTX) and lapatinib (LPT) in a polymeric micelle formulation as a novel drug delivery system using high-performance liquid chromatography (HPLC). The assay was performed using the C18 MZ-Analytical Column (5 μm, 150 × 4.6 mm, OSD-3) which was protected with the C18 pre-column (5 μm, 4.0 × 4.6 mm, OSD-3). The mobile phase was composed of acetonitrile and water (70/30; V/V) with a flow rate of 0.5 mL/min and detection wavelength of 227 nm. Accuracy was reported as the relative error and was found to be less than 6.8%. The interday assay was evaluated to be 3.22% and 5.76% RSD for PTX and LPT, respectively. The intraday precision was found to be at its maximum value of 5.83% RSD. The limit of detection for both PTX and LPT was found to be 1 µg/mL by means of the newly developed method. The limit of quantitation for PTX and LPT was found to be 5 µg/mL. The calibration curves for both drugs were linear in the concentration range of 5 to 80 μg/mL. In vitro release for both drugs from the polymeric micelle was evaluated using the newly developed analysis method.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Development and Validation of Rapid RP-HPLC-DAD Analysis Method for Simultaneous Quantitation of Paclitaxel and Lapatinib in Polymeric Micelle Formulation

et al. 2016

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“…Alternatively, dFdCMP produces difluoromonophosphate deoxyuridine via 2′-deoxycytidine 5′-monophosphate (dCMP) deaminase, and then creates dFdU [27]. Therefore, some methods for detecting the concentration of dFdC metabolites and studying pharmacokinetics have been established [28], among which reverse phase high-performance liquid chromatography (RP-HPLC) was the most efficient and sensitive [29–31].…”

Section: Introductionmentioning

confidence: 99%

Concentration changes in gemcitabine and its metabolites after hyperthermia in pancreatic cancer cells assessed using RP-HPLC

Jin

Xie

et al. 2019

Cell Mol Biol Lett

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Background Gemcitabine (2′,2′-difluoro-2′-deoxycytidine;dFdC) is a first-line chemotherapy drug for pancreatic cancer. Recently, a synergistic anti-tumor treatment of dFdC and hyperthermia has achieved good clinical results, but there are few reports on the molecular mechanism influenced by hyperthermia. This study is an initial exploration of the effects of hyperthermia on changes in the concentration of dFdC and its metabolites in pancreatic cancer cells. The aim is to provide a theoretical basis for clinical detection and pharmacokinetic research. Methods PANC-1 cells at logarithmic growth phase were used as the experimental object. The MTT assay was performed to determine the half maximal inhibitory concentration (IC 50 ) of dFdC. After PANC-1 cells were cultured in DMEM medium containing IC 50 dFdC and treated with hyperthermia at 41 °C or 43 °C, changes in the concentration of dFdC, 2′,2′-difluorodeoxyuridine (dFdU) and difluorodeoxycytidine triphosphate (dFdCTP) in the cells were tested using an optimized reverse phase high-performance liquid chromatography (RP-HPLC) protocol. Results We found that 41 °C and 43 °Chyperthermia gave rise to a decrease in dFdC and dFdU content. At 41 °C, the levels respectively fell to 9.28 and 30.93% of the baseline, and at 43 °C, to 24.76 and 57.80%, respectively. The dFdCTP content increased by 21.82% at 41 °C and 42.42% at 43 °C. Conclusion The two heat treatments could alter the mechanism of dFdC metabolism in PANC-1 cells. The effect of 43 °C hyperthermia is more significant. Our observations may be instrumental to explaining the higher anti-tumor efficacy of this combination therapy.

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“…For the determination of lapatinib in tablets, a simple, selective, fast, accurate, and cost-effective method of reverse-phase highperformance liquid chromatography coupled with an ultraviolet detector (RP-HPLC-UV) using an internal standard (IS) has been developed [26]. Methods that use an IS are most suitable for quality control of drugs because they eliminate errors associated with sample preparation and variability between analyses, increasing the method's accuracy and precision.…”

Section: Standardization Of Lapatinib In the Dosage Formmentioning

confidence: 99%

Modern Instrumental Methods for Qualitative and Quantitative Analysis of Lapatinib in Biological Fluids and Dosage Forms (Review)

2022

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Lapatinib is a small molecule, a heterocyclic quinazoline derivative. The drug is used for targeted therapy of patients with breast cancer, in which there is overexpression of the human epidermal growth factor receptors (HER/ErbB). This review is devoted to studying modern instrumental methods of qualitative and quantitative analysis of lapatinib, which can be used both for quality control and standardization (of bulk pharmaceuticals and dosage forms) and pharmacokinetics studies of a drug. Reverse-phase high-performance liquid chromatography (RP-HPLC) is mainly used to identify lapatinib in tablets. Depending on the purpose of the study, various detectors are used (ultraviolet or diode-matrix detector), which makes it possible to determine not only the native compound but also the products of its degradation. Definition of lapatinib in the presence of degraded products is necessary for forced degradation studies to determine drug stability. When a drug is being developed, it is important to define and understand its pharmacokinetics. For such studies, high-performance liquid chromatography (HPLC) coupled with the mass selective detector is often used. It allows determining lapatinib in biological fluids. However, these methods are not applicable for identifying the drug directly in dosage forms and require further development and validation.

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A validated RP-HPLC method for the estimation of lapatinib in tablet dosage form using gemcitabine hydrochloride as an internal standard

Cited by 16 publications

References 12 publications

Development and Validation of Rapid RP-HPLC-DAD Analysis Method for Simultaneous Quantitation of Paclitaxel and Lapatinib in Polymeric Micelle Formulation

Development and Validation of Rapid RP-HPLC-DAD Analysis Method for Simultaneous Quantitation of Paclitaxel and Lapatinib in Polymeric Micelle Formulation

Concentration changes in gemcitabine and its metabolites after hyperthermia in pancreatic cancer cells assessed using RP-HPLC

Modern Instrumental Methods for Qualitative and Quantitative Analysis of Lapatinib in Biological Fluids and Dosage Forms (Review)

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