Development and Validation of a Stability Indicating Liquid Chromatographic Method for the Determination of Milnacipran in Bulk and its Formulations

Singhvi, Gautam; Gampa, Gautham; Saha, Ranendra N.

doi:10.2174/1573412911309020010

Cited by 10 publications

(5 citation statements)

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“…These parameters were used to verify the complete performance of the chromatography system. To determine the system suitability, the acceptance criteria were considered as RSD ≤ 2% for the peak area and retention time, resolution > 2, tailing factor < 2, and theoretical plate > 3000 for both the drugs .…”

Section: Methodsmentioning

confidence: 99%

Stability indicating liquid chromatographic method for simultaneous quantification of betamethasone valerate and tazarotene in in vitro and ex vivo studies of complex nanoformulation

Rapalli

Singhvi

Gorantla

et al. 2019

J of Separation Science

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Low‐potency corticosteroid betamethasone valerate and vitamin‐A tazarotene are used in combination for effective treatment of psoriasis. There is no robust high‐performance liquid chromatography analytical technique available for simultaneous estimation of betamethasone valerate and tazarotene in conventional and nanocarriers based formulations. A simple, accurate, robust isocratic high‐performance liquid chromatography method was developed for simultaneous estimation of betamethasone valerate and tazarotene in topical pharmaceutical formulations. The developed method was validated as per the regulatory guidelines. The validated method was linear over the concentration range of 150–6000 ng/mL (r2 > 0.999) at 239 nm wavelength. Limits of detection and quantification of two analytes were 50 and 150 ng/mL, respectively. The %relative standard deviation for intraday and interday precision was less than 2%. The method was also evaluated in the presence of forced degradation conditions. The developed method was successfully applied for in vitro and ex vivo drug release studies of in‐house designed nanoformulations.

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Section: Methodsmentioning

confidence: 99%

Stability indicating liquid chromatographic method for simultaneous quantification of betamethasone valerate and tazarotene in in vitro and ex vivo studies of complex nanoformulation

Rapalli

Singhvi

Gorantla

et al. 2019

J of Separation Science

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“…Accuracy was denoted as % bias and the precision as % relative standard deviation (RSD). The acceptance requirement for precision and accuracy of quality control samples according to regulatory criteria was ≤ ± 2% and ≤ ± 10% RSD, respectively [30].…”

Section: Accuracy and Precisionmentioning

confidence: 99%

Design of experiment-driven stability-indicating RP-HPLC method for the determination of tofacitinib in nanoparticles and skin matrix

2021

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Background Tofacitinib—an oral JAK inhibitor—has been recently approved by US FDA to treat moderate to severe RA. The delivery of tofacitinib to specific inflammation site at joint via topical route using nanoformulations helps in managing the potential adverse effects. The objective is to develop and validate a simple, specific, and sensitive stability-indicating HPLC method for quantification of tofacitinib in topical nanoformulations and different matrices (adhesive tape, and skin layers, i.e., stratum corneum, viable epidermis, and dermis). The major objective was to avoid use of instruments like LC–MS/MS and to ensure a widespread application of the method. Result A 32 factorial ‘design of experiments’ was applied to optimize process variables, to understand the effect of variables on peak properties. The calibration curve showed regression coefficient (R2) 0.9999 and linearity in the concentration range of 50 to 15,000 ng/mL, which is suitable for the analysis of conventional dosage forms and nanoformulations. Method validation was performed as per ICH guideline Q2 (R1). The accuracy by recovery studies ranged between 98.09 and 100.82%. The % relative standard deviations in intraday and interday precisions were in the range of 1.16–1.72 and 1.22–1.80%, respectively. Forced degradation studies indicated the specificity of method and showed stability-indicating potential for tofacitinib peak. Conclusion The validated method provides a quantification method of tofacitinib in the presence of formulation excipients, dissolution media, and skin tissues in detail. In addition, the method was successfully utilized for determination of various dermatokinetics profile of tofacitinib.

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“…Extensive literature survey did not reveal any suitable simple liquid chromatographic method for routine estimation of leuprolide acetate in aqueous inprocess matrix and finished formulation samples. Therefore, the purpose of this study was to develop and validate a rapid simple and sensitive liquid chromatographic method for the determination of leuprolide acetate in bulk as well as in formulations as per the standard guidelines [7] and published reports [8][9][10]. It is also desirable that such method should be cost effective and robust enough for easy acceptability at industry and academic research environment.…”

Section: Liquid Chromatographic Estimation Of Leuprolide Acetate In Bmentioning

confidence: 99%

Liquid Chromatographic Estimation of Leuprolide Acetate in Bulk and Microsphere Formulation

Pittala¹,

Sastry²,

Krishna³

et al. 2018

Asian J. Chem.

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Development of a sensitive, robust and validated analytical method for determination of an active drug in sample matrix is the key component to ensure identity, purity and quality of drug and formulations. The aim of the proposed work was to develop and validate a simple, rapid, sensitive, robust and cost effective high performance liquid chromatographic method for the estimation of leuprolide acetate in bulk and formulations for routine analysis. The method was developed using Supelco-C18 (150 × 4.6 mm, 5 µm) analytical column and mobile phase consisting of a mixture of 10 mM sodium acetate buffer and acetonitrile in 70:30 ratios. Developed method was validated as per ICH guidelines. The method has demonstrated linearity over the range of 1 to 50 µg/mL with regression equation, peak area = 7364.6 × concentration (µg/mL) -10051 (R 2 = 0.998). The method demonstrated selectivity with no interference of formulation excipients and mobile phase. The developed method showed good and consistent recovery (98.85 to 101.05 %). Method indicated acceptable repeatability with % RSD not more than 1.58. The method was found to be sensitive with detection and quantification limit 0.26 and 0.79 µg/mL, respectively. Also, developed method was successfully applied for compatibility study and determination of entrapment efficiency of prepared microsphere formulation. The method was found to be accurate, precise, sensitive and selective for the determination leuprolide acetate in bulk and formulations.

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Development and Validation of a Stability Indicating Liquid Chromatographic Method for the Determination of Milnacipran in Bulk and its Formulations

Cited by 10 publications

References 0 publications

Stability indicating liquid chromatographic method for simultaneous quantification of betamethasone valerate and tazarotene in in vitro and ex vivo studies of complex nanoformulation

Stability indicating liquid chromatographic method for simultaneous quantification of betamethasone valerate and tazarotene in in vitro and ex vivo studies of complex nanoformulation

Design of experiment-driven stability-indicating RP-HPLC method for the determination of tofacitinib in nanoparticles and skin matrix

Liquid Chromatographic Estimation of Leuprolide Acetate in Bulk and Microsphere Formulation

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