Development and Validation of RP-HPLC Method for Simultaneous Estimation of Olmesartan and Hydrochlorothiazide in Tablet Dosage Form

Rudrapal, Mithun; Oduri, Madhavi; Samidala, Nageswara; Kıran, B.; Junejo, Julfikar; K.N.Singh,; Chakraborty, Tapash; Debnath, Manabendra

doi:10.13005/ojc/310236

Cited by 18 publications

(9 citation statements)

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“…The summary of optimum chromatographic conditions is depicted in Table 1. After method development, validation of the developed method was performed in terms of the following parameters: linearity, accuracy, precision, robustness, limit of detection (LOD), limit of quantitation (LOQ) and specificity [8][9][10][11][12] .…”

Section: Resultsmentioning

confidence: 99%

Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

Rudrapal¹,

Hussain²

2020

J. Drug Delivery Ther.

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A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms. Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

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Section: Resultsmentioning

confidence: 99%

Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

Rudrapal¹,

Hussain²

2020

J. Drug Delivery Ther.

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“…Linearity, accuracy, precision, robustness, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), specificity, and system suitability studies were carried out. [12][13][14][15][16][17][18][19]…”

Section: Methods Validationmentioning

confidence: 99%

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Rudrapal¹

2021

AJP

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Objective: The objective of this study was to develop a new and simple reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of riluzole (RZ) and levodopa (LD) in the marketed tablet dosage form. Materials and Methods: The chromatographic separation was achieved on a RP hypercil C 18 column (250 × 4.6 mm i.d., 5 µm) using a mobile phase consisting of methanol and water (75:25 v/v) at a flow rate of 1.0 ml/min with the ultraviolet detection wavelength of 273 nm at ambient temperature. The developed method was validated as per the International Council on Harmonization guideline for linearity, accuracy, precision, robustness, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), and specificity. Results: Results of validation studies were found satisfactory with % relative standard deviation values of <2% indicating good specificity, validity, and reliability of the method. The method showed good linearity over the concentration range of 20-80 µg/ml with correlation coefficient (r 2 ) values of 0.990and 0.999 for RZ and LD, respectively. The mean percentage recoveries were between 99.46-99.80% and 100.15-101.24% for RZ and LD, respectively. The LOD and LOQ values were found to be 0.036and 0.012 µg/ml, and 0.110and 0.036 µg/ml for RZ and LD, respectively. The assay of RZ and LD in the marketed tablet formulation was found to be 99.67and 98.95%, respectively. Conclusion: The RP-HPLC method is reported to be simple, specific, accurate, and precise. The proposed method can be successfully applied for the routine analysis of RZ and LD in the bulk drugs as well as in combined pharmaceutical dosage forms.

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“…After reviewing the literature extensively, different methods have been published for the determination of OLM and HCZ in their mixture. The binary mixture was analyzed by differrent spectrophotometric [6][7][8][9][10][11][12], spectrofluorimetric [13], electrophoretic [14], HPTLC [15][16][17][18], HPLC [15,[19][20][21][22][23][24][25][26][27][28][29][30][31], and UPLC [32,33] methods. The studied mixture was also determined in plasma by LC-MS [34][35][36].…”

Section: Introductionmentioning

confidence: 99%

Different spectrophotometric and TLC-densitometric methods for determination of olmesartan medoxomil and hydrochlorothiazide and their degradation products

2018

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In this work, multivariate calibration models and TLC-densitometric methods have been developed and validated for quantitative determination of olmesartan medoxomil (OLM) and hydrochlorothiazide (HCZ) in presence of their degradation products, olmesartan (OL) and salamide (SAL), respectively. In the first method, multivariate calibration models including principal component regression (PCR) and partial least square (PLS) were applied. The wavelength range 210-343 nm was used and data was auto-scaled and mean centered as pre-processing steps for PCR and PLS models, respectively. These models were tested by application to external validation set with mean percentage recoveries 99.78, 100.01, 100.41 and 100.46% for OLM, HCZ, OL and SAL, respectively, for PLS model and also, 100.22, 100.40, 102.25 and 100.13% for them, respectively, for PCR model. The second method is TLC-densitometry at which the chromatographic separation was carried out using silica gel 60F254 TLC plates and the developing system consisted of a mixture of ethyl acetate:chloroform:methanol: formic acid:tri-ethylamine (60:40:4:4:1, by volume) with UV-scanning at 254 nm. The developed methods were successfully applied for determination of OLM and HCZ in their pharmaceutical dosage form. Also, statistical comparison was made between the developed methods and the reported method using student’s-t test and F-test and results showed that there was no significant difference between them concerning both accuracy and precision.

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Development and Validation of RP-HPLC Method for Simultaneous Estimation of Olmesartan and Hydrochlorothiazide in Tablet Dosage Form

Cited by 18 publications

References 1 publication

Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

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Different spectrophotometric and TLC-densitometric methods for determination of olmesartan medoxomil and hydrochlorothiazide and their degradation products

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