Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Cilnidipine

Tiwari, Balakrishna; Shirsat, Mrunal K.; Kulkarni, Amol A.

doi:10.22270/jddt.v10i1.3846

Cited by 12 publications

(4 citation statements)

References 7 publications

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“…An extensive literature review reveals that different analytical methods like HPTLC [4,5], RP-HPLC [6][7][8][9][10][11][12], RP-UPLC [13], UV [14], and LC-MS [15,16] have been reported for the estimation of AZL. HPTLC [17][18][19], UV [20][21][22] and RP-HPLC [23][24][25][26][27][28] methods have been reported for analysis of CLN in the bulk and pharmaceutical dosage form.…”

Section: Introductionmentioning

confidence: 99%

Liquid chromatographic method for simultaneous estimation of anti‐hypertensive drug combination Azilsartan Medoxomil and Cilnidipine

Solanki¹,

Panday²,

Shah³

et al. 2023

Separation Science Plus

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A combination of Azilsartan Medoxomil and Cilnidipine is prescribed in the treatment of Hypertension. An accurate and precise high‐performance liquid chromatographic method has been developed for the estimation of Azilsartan Medoxomil and Cilnidipine in a combined tablet dosage form. Symmetry C18 (250 × 4.6 mm, 5 μm) column was used as the stationary phase, and methanol:water (85:15 v/v; pH 3.5) was used as the mobile phase. The method was linear in the concentration range of 4–20 μg/ml for Azilsartan Medoxomil and 1–5 μg/ml for Cilnidipine with a correlation coefficient (r2) 0.995 for Azilsartan Medoxomil and 0.995 for Cilnidipine. The proposed method was validated with respect to linearity, accuracy, precision, and robustness as per International Council on Harmonization Q2 (R1) guideline. A forced degradation study was performed to find out the intrinsic stability of the molecules. The degradation products were well resolved from the drug peak and did not interfere with the analysis. The method was successfully applied for the analysis of Azilsartan Medoxomil and Cilnidipine in combined tablet formulation.

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Section: Introductionmentioning

confidence: 99%

Liquid chromatographic method for simultaneous estimation of anti‐hypertensive drug combination Azilsartan Medoxomil and Cilnidipine

Solanki¹,

Panday²,

Shah³

et al. 2023

Separation Science Plus

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“…Cilnidipine (CIL) is a calcium channel blocker used to treat heart conditions such as angina and excessive blood pressure [18]. According to the literature study, several stability-indicating RP-HPLC methods have been reported for the estimation of CIL alone and with other drugs [19][20][21][22][23][24][25]. Methanol and acetonitrile were used as mobile phase components and diluents for sample pretreatment in the reported chromatographic procedures.…”

Section: Introductionmentioning

confidence: 99%

Green analytical chemistry‐driven response surface modeling to stability‐indicating chromatographic method for estimation of cilnidipine and application of high‐performance thin‐layer chromatography–mass spectrometry for characterization of degradation products

Prajapati¹,

Dixit²,

Pulusu

et al. 2023

J of Separation Science

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Cilnidipine is a calcium channel blocker that is used to treat cardiac diseases such as angina and high blood pressure. Several column and planar chromatographic methods for estimating cilnidipine in pharmaceutical dosage forms have been documented. However, these method developments have been carried out employing organic solvents such as acetonitrile, methanol, toluene, chloroform, and others as mobile phase components or as sample pretreatment diluents. These organic solvents are neurotoxic and teratogenic to humans and aquatic animals, according to International Council for Harmonization Q3C (R8) recommendations. According to the green analytical chemistry approach, such organic solvents should be reduced or removed during the development of chromatographic methods for environmental protection and the safety of human and aquatic animal life. As a result, the stability-indicating chromatographic estimation of cilnidipine was performed utilizing less toxic organic solvents. To prevent organic solvent waste during method development, mobile-phase optimization was performed using the design of experiment-based response surface modeling. Cilnidipine has been subjected to hydrolysis, oxidation, photolysis, and dry-heat decomposition to determine its stability. The greenness profiles of the suggested and published chromatographic methods were examined using the national environment method index, analytical greenness calculator, green analytical procedure index software, and eco-scale assessment tool.

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“…The third target CLN is a novel calcium channel blocker used to manage hypertension and chemically known as (±)-(E)-Cinnamyl 2-methoxyethyl-1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate (Supporting Information Figure S1C) [20]. The literature survey revealed that HPLC [21][22][23][24][25][26], HPTLC [27][28][29], and LC-MS [30][31][32][33][34][35] procedures are reported to date for quantification of MET, TEL, and CLN individually and in combination with different drugs. However, no analytical methods are reported for MET, TEL, and CLN's simultaneous quantification in their newly fixed-dose combination.…”

Section: Introductionmentioning

confidence: 99%

Analytical eco‐scale and quality by design‐oriented liquid chromatography method for simultaneous quantification of metoprolol succinate, telmisartan, and cilnidipine in their fixed‐dose combination

Panda

Dutta

Bera

et al. 2021

Separation Science Plus

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A new combination of metoprolol succinate, telmisartan, and cilnidipine is recently approved to treat hypertension effectively. A reversed‐phase liquid chromatography method was developed to quantify the said compounds, combining analytical eco‐scale and quality‐by‐design approach. The former one revealed an excellent green score for the present method. Later, method variables were assessed for risks and optimized using the quality‐by‐design‐oriented method development. The optimization process included using a Box‐Behnken design, and the obtained response surfaces for resolution amongst target peaks were mapped systematically. The optimal separation conditions employed a mobile phase of methanol: 0.01 M KH2PO4 buffer of pH 3.0 (70:30, %v/v) flowing at a rate of 1.0 mL/min on a C18 column with diode array detection at 240 nm. All three analyte peaks were well separated from each other with a resolution greater than 2.0. The analytical method was linear (2.5‐80 μg/mL) for target compounds with accuracy (>99%), and precision (<1%) results complying with regulatory requirements. The results of detection and quantitation limits, solution stability, and system suitability limit were good and acceptable. The current method selectively quantified the analytes from commercial dosage forms. Overall a green analytical method is developed and suitable for estimating metoprolol, telmisartan, and cilnidipine simultaneously in their combined pharmaceutical formulations.

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Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Cilnidipine

Cited by 12 publications

References 7 publications

Liquid chromatographic method for simultaneous estimation of anti‐hypertensive drug combination Azilsartan Medoxomil and Cilnidipine

Liquid chromatographic method for simultaneous estimation of anti‐hypertensive drug combination Azilsartan Medoxomil and Cilnidipine

Green analytical chemistry‐driven response surface modeling to stability‐indicating chromatographic method for estimation of cilnidipine and application of high‐performance thin‐layer chromatography–mass spectrometry for characterization of degradation products

Analytical eco‐scale and quality by design‐oriented liquid chromatography method for simultaneous quantification of metoprolol succinate, telmisartan, and cilnidipine in their fixed‐dose combination

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