DOE-Based Stability Indicating RP-HPLC Method for Determination of Lacidipine in Niosomal Gel in Rat: Pharmacokinetic Determination

Qumbar, Mohd; Ameeduzzafar,; Ali, Javed; Imam, Syed Sarim; Fazil, Mohd; Ali, Asgar

doi:10.4172/2153-2435.1000314

Cited by 9 publications

(4 citation statements)

References 20 publications

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“…500 µl of 10 µg/mL Ketoconazole standard solution (IS) was added to the specified dilutions of the drug solutions in the Eppendorf tubes. Further, these solutions were centrifuged for 20 min at 10,000 rpm, and the supernatant was extracted and injected into the chromatographic system for analysis 6 . All these solutions were stable for seven days when stored at room temperature (20-25 ºC) and were used within one week.…”

Section: Experimental Design For Developed Methods Of Hplcmentioning

confidence: 99%

Untitled

2019

IJPSR

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A novel method of estimation and validation of Sertaconazole nitrate (SER) by Reverse Phase-High Performance Liquid Chromatography coupled with Ultra-violet detection was developed which had high potential in determining drug concentration with more precision and high accuracy. The process of elution was conducted using Phenomenex C 18 (250 mm × 4.6 mm i.d., 5.0 μm) using 0.01M monobasic sodium phosphate and acetonitrile in a ratio of 28:72% v/v as mobile phase at 4.5 pH and a flow rate of 1.0 mL/min. Detection was carried out using a UV detector at 260 nm. This precise method was linear between a range of 10 to 500 μg/ml with R 2 close to one (0.999). The limit of detection (LOD) and limit of quantification (LOQ) of SER was found to be 0.1 μg/ml and 0.15 μg/ml respectively. The method was validated for accuracy, precision, linearity, LOD, LOQ, and robustness. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The 3-level 2-factor facecentred central composite design was employed using Design Expert Software ver. 7.0.0 to examine the effect of independent chromatographic factors like pH of the mobile phase and the ratio between 0.01M monobasic sodium phosphate and acetonitrile on the dependent factors like peak area, theoretical plates and tailing factor. The ANOVA studies proved that the model employed for this study was significant. This method can be used as a more convenient and efficient option for the analysis of SER to establish the quality of the drug substance during routine analysis with consistent and reproducible results.

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Section: Experimental Design For Developed Methods Of Hplcmentioning

confidence: 99%

Untitled

2019

IJPSR

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“…Several published studies reported the relevance of quality by design approach for optimization of the HPLC method and provide prized information about the interaction effect of the variable over the response as well as give appropriated chromatographic condition in which drug is well separated [ 12 , 13 ]. The analytical quality by design (AQbD) is a novel tool for optimization of HPLC instrumental conditions such as flow rate, the solvent system, solvent ratio, the effect of temperature, injection volume, the resolution of the drug (Rt) as well as cost and effort.…”

Section: Introductionmentioning

confidence: 99%

“…It gives a lesser number of runs in the various compositions of independent variables. There are many published research works on optimization of RP-HPLC using QbD (Box–Behnken design) reported such as voriconazole [ 20 ], methotrexate [ 21 ], dapagliflozin [ 12 ], lacidipine [ 13 ], timolol maleate [ 22 ], risperidone [ 23 ], and temozolomide [ 24 ]. No method has been reported on the RP-HPLC method using a QbD approach for atorvastatin.…”

Section: Introductionmentioning

confidence: 99%

Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method

Alruwaili

2021

International Journal of Analytical Chemistry

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The use of analytical quality by design (AQbD) approach in the optimization of the high-performance liquid chromatography (RP-HPLC) method is a novel tool. Three factors and three levels of Box–Behnken statistical design (BBD) were used for method optimization and analysis of atorvastatin. The mobile phase (acetonitrile: water), flow rate (Rt), and UV wavelength were used as independent variables. Their effects were observed in the area of the chromatogram (AU), retention time (Rt, min), and tailing factor (%). The optimized HPLC condition was found as acetonitrile:water (50 : 50), flow rate (0.68 ml/min), and UV wave length (235 nm). It gives the retention time of 2.43 min with the linearity range of 5–30 μg/ml with a high regression value (r2 = 0.999). The method was found to be precise and accurate with low % RSD (<5%). The refrigeration stability indicated that atorvastatin was stable. The force degradation study showed that the atorvastatin was fully unstable in UV light and stable in 0.1 M basic condition. It concluded that this QbD optimized method is suitable for quantification of the atorvastatin from the formulation as well as pharmacokinetic parameters.

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“…In the present study, an antihypertensive agent lacidipine, chemically known as (E)‐4[2‐[3‐(1,1‐dimethyl ethoxy)‐3‐oxo‐1‐propenyl]phenyl]‐1,4‐dihydro‐2,6‐dimethyl‐3,5‐pyridine dicarboxylic acid diethyl ester was chosen for the purpose (Figure ) . Few LC methods are reported for estimation of lacidipine present in the dosage form and biological fluids . However, the reported methods for estimation of lacidipine in dosage forms have several drawbacks like the use of C‐12 column and column oven , non‐stability indicating in nature , longer run time upto 60 min and gradient elution .…”

Section: Introductionmentioning

confidence: 99%

Analytical lifecycle management approach: Application to development of a reliable LC method for estimation of lacidipine

Panda

Bera

Acharjya

et al. 2019

Separation Science Plus

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Lack of quality analytical methods with assured robustness and reliability has always been a serious concern for drug regulatory agencies. In the present study, a contemporary approach of analytical life‐cycle management resulted in the robust and reliable chromatographic analysis of lacidipine at a retention time of 5.1 min on a C‐18 column. Method variables such as %acetonitrile, flow rate, and pH were optimized using the design of experiment approach and their effect on critical quality attributes was studied. The attributes of the present study were significantly influenced by %acetonitrile and flow of the mobile phase. The newly optimized method was validated for various parameters with values in accordance with federal guidance. The lifecycle approach proved to be beneficial for routine application with a potential of future bio‐analytical utility.

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DOE-Based Stability Indicating RP-HPLC Method for Determination of Lacidipine in Niosomal Gel in Rat: Pharmacokinetic Determination

Cited by 9 publications

References 20 publications

Untitled

Untitled

Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method

Analytical lifecycle management approach: Application to development of a reliable LC method for estimation of lacidipine

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