Novel RP-HPLC Method for Simultaneous Estimation of Doxofylline and Sertraline in Bulk and Tablet Dosage Form

Eswarudu, M.M.; Kumar, Y. Ravi; Eswaraiah, M. Chinna

doi:10.5958/0974-4150.2015.00086.3

Cited by 3 publications

(1 citation statement)

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“…Several analytical methods were reported for Telmisartan assay include: Spectrophotometry as single drug [18][19][20], as mixture with other drugs [21][22][23][24][25][26][27], Spectrofluorimetric methods as a mixture with other drugs [28,29]. Also many HPLC procedures have been published for its quantitation in its single form [30][31][32][33] and as mixture with others [34][35][36][37][38][39][40]. Therefore, it was desirable to develop simple, accurate, cheap and rapid procedure that could be utilized for simultaneous assessment of Cilostazol and telmisartan.…”

Section: Introductionmentioning

confidence: 99%

Selective Methods for Cilostazol Assay in Presence of its Oxidative Degradation Product and Co Formulated Telmisartan Application to Tablet Formulation

Ibrahim¹,

M²,

El-Aziz³

2016

J Chromatogr Sep Tech

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A high performance liquid chromatographic method characterized by its rapidness and sensitivity was developed and validated for quantitation of Cilostazol (CIL) and Telmisartan (TEL) in raw material, their synthetic mixture using isocratic technique and monolithic C8 column (3 mm × 4.6 mm i.d., 2 μm pore size highly porous). The mobile phase composed of acetonitrile:0.03 M dihydrogen phosphate buffer (40:60, v/v) at pH 4.5. Quantification was achieved through UV detection at 257 nm using flow rate of 1 mL/min, and Dipyridamole (DIP) was used as internal standard. DIP, CIL, and TEL, retention times were 2.2, 3.9 and 5.1 min. respectively. Peak area ratios of each drug to Dipyridamol internal standard were plotted against concentration of each drug and linear relations were obtained in the range of 0.5-15 μg/mL for CIL 0.25-20 μg /mL for TEL. The method was successfully utilized for the assay of CIL and TEL synthetic mixture. Stability-indicating assay methods (SIAM) were mentioned for separation of CIL in presence of its degradation products. Cilostazol was subjected to acid and alkali hydrolysis, oxidation and photochemical degradation. It was stable under acidic, basic and ultraviolet degradation conditions, but undergoes oxidative degradation, therefore the drug was separated from its oxidative degradation product using our proposed high performance liquid chromatographic and derivative ultraviolet spectrophotometric methods. The first derivative method (D1) depend on measuring the amplitude values at 227 and 257 nm for Cilostazol and oxidative degradate, respectively. From calibration plots, linearity was obtained in the range of 1-35 μg/mL for Cilostazol and 2-50 μg/mL for oxidative degradate. Chromatographic separation of Cilostazol from its oxidative degradate was proceeded using the same mobile phase at pH 3.3. All methods were validated statistically as per International Conference on Harmonization (ICH) recommendations for the studied drugs and Cilostazol oxidative degradate in the concentration range of the suggested methods and applied on pure materials and synthetic mixture.

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Section: Introductionmentioning

confidence: 99%

Selective Methods for Cilostazol Assay in Presence of its Oxidative Degradation Product and Co Formulated Telmisartan Application to Tablet Formulation

Ibrahim¹,

M²,

El-Aziz³

2016

J Chromatogr Sep Tech

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Simultaneous quantification of brexpiprazole and sertraline HCl in synthetic mixture by thin-layer chromatography method

Vahora

Chhalotiya

Kachhiya

et al. 2021

JPC-J Planar Chromat

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Development and validation of RP-HPLC method for quantification of sertraline in nanofiber formulation

A. Hajare,

A. Ghatge,

S. Patil

2023

RJPT

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A selective serotonin reuptake inhibitor (SSRI) sertraline (SER) is one of the most often prescribed medications for the treatment of depression. The current study was aimed to develop a new, reliable, simple, and reproducible method for the estimation of SER in nanofiber formulation. The RP-HPLC method selected for estimation and validation was developed by choosing a mobile phase phosphoric acid (0.5%) and acetonitrile at the ratio 45: 55 %v/v, with a flow rate of 1 mL/min at a temperature of 30 ℃. The linearity of the solution was detected at 274 nm within the concentration range from 20 -120 µg/mL with a correlation value (R2) of 0.999 indicating a very strong relationship between dependent and independent variables suggesting the accuracy of the method selected. The concentration of SER in nanofibers was determined by the currently developed method. Validation parameters were used to evaluate, specificity, linearity, sensitivity, accuracy, precision, and ruggedness. About 98-102 (%v/v) of SER was found to be within standard limits and compliant with the standards set by the International Council of Harmonization (ICH) demonstrating the accuracy of the method used. An ICH Q2 (R1) guideline gives guidance on validation for analytical techniques. The RP-HPLC method developed can be used effectively for the analysis of various pharmaceutical dosage forms containing SER.

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Novel RP-HPLC Method for Simultaneous Estimation of Doxofylline and Sertraline in Bulk and Tablet Dosage Form

Cited by 3 publications

References 0 publications

Selective Methods for Cilostazol Assay in Presence of its Oxidative Degradation Product and Co Formulated Telmisartan Application to Tablet Formulation

Selective Methods for Cilostazol Assay in Presence of its Oxidative Degradation Product and Co Formulated Telmisartan Application to Tablet Formulation

Simultaneous quantification of brexpiprazole and sertraline HCl in synthetic mixture by thin-layer chromatography method

Development and validation of RP-HPLC method for quantification of sertraline in nanofiber formulation

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