Chromatographic Separation and in Vitro Dissolution Assessment of Tenofovir disoproxil fumarate, Emtricitabine and Nevirapine in a Fixed Dose Combination of Antiretrovirals

Objective: To develop a UV-derivative spectrophotometric method with zero-crossing determinations for the simultaneous quantification of ibuprofen (IBU) and caffeine (CAF) in fixed-dose combination formulations (soft gelatin capsules). The proposed method was validated, and it was applied to determine the in vitro dissolution performance of IBU and CAF from a commercial formulation. Methods: The method is based on the use of the second-derivatives of the zero-order spectra and measurement at zero-crossing wavelengths. Linearity, accuracy, precision, stability, and influence of the filter were evaluated. Dissolution profiles of IBU and CAF were obtained with the USP Apparatus 2 at 100 rpm and 900 ml of 0.1 M phosphate buffer pH 7.4 as dissolution medium. Dissolution samples were treated with the proposed UV-derivative method and results were compared with data previously published. Results: The zero-crossing points for the determination of IBU and CAF were found at 235.6 nm and 218.8 nm, respectively. The method was linear in the range of 7.5-15 µg/ml for IBU and 5-25 µg/ml for CAF (R2>0.999, *P<0.05). The precision and accuracy of the method were within acceptable criteria (CV<0.99% and recovery 97.97% for IBU and CV<1.76% and recovery 99.05% for CAF). Fiberglass filters were the best option to filter samples and stability of all drugs was adequate when solutions were stored at 25 °C during 24 h. Dissolution of IBU and CAF at 60 min was 99-100% with dissolution profiles of sigmoidal S-shape. Weibull function and Logistic were the best-fit models that describe the in vitro dissolution performance of both drugs. Conclusion: The proposed UV-derivative method allows the simultaneous determination of IBU and CAF in fixed-dose combination formulations. The method generates reliable information that can be compared with published data. The proposed UV-derivative method is rapid and simple and can be easily adopted for routine analysis of IBU and CAF.

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COMPARATIVE IN VITRO DISSOLUTION STUDY OF A NOVEL ACECLOFENAC AND PARACETAMOL FIXED DOSE COMBINATION WITH MARKETED FORMULATION IN INDIA

Indian Research Journal of Pharmacy and Science ◽

10.21276/irjps.2019.6.1.8 ◽

2019 ◽

Vol 6 (1) ◽

pp. 1825-1831

Author(s):

Sunil Agarwal ◽

◽

Sambhaji Deshmukh ◽

Hiten Saresa ◽

Kapil Dev Mehta ◽

...

Keyword(s):

Fixed Dose Combination ◽

In Vitro Dissolution ◽

Fixed Dose ◽

Dissolution Study ◽

Dose Combination

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Evaluation of assay and in-vitro dissolution profile of certain fixed-dose combination using green analytical method

Annales Pharmaceutiques Françaises ◽

10.1016/j.pharma.2020.07.007 ◽

2021 ◽

Vol 79 (1) ◽

pp. 3-15

Author(s):

H.M. Lotfy ◽

R.H. Obaydo ◽

A.A. Sakur

Keyword(s):

Analytical Method ◽

Fixed Dose Combination ◽

In Vitro Dissolution ◽

Fixed Dose ◽

Dissolution Profile ◽

Dose Combination

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Comparative in vitro dissolution studies of fixed-dose combination formulations: analgesic tablets of acetaminophen/caffeine

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v12i2.4634 ◽

2021 ◽

Vol 12 (2) ◽

pp. 1063-1073

Author(s):

Medina-López J R ◽

Sánchez-Badajos S ◽

Carreto-Jiménez R M ◽

García-Hernández P ◽

Contreras-Jiménez J M

Keyword(s):

Fixed Dose Combination ◽

In Vitro Dissolution ◽

Fixed Dose ◽

Dissolution Studies ◽

Derivative Method ◽

Dose Combination ◽

Usp Apparatus ◽

Usp Apparatus 2

A simple and rapid UV derivative method with zero-crossing determinations was developed for estimation of acetaminophen (ACE) and caffeine (CAF) in fixed-dose combination formulations. The first-derivative of standard solutions of both drugs were used and ACE and CAF were quantified at 273.0 and 216.5 nm, respectively. The method was validated, and it was applied to dissolution studies with the USP Apparatus 2 and flow-through cell (USP Apparatus 4). Dissolution profiles comparisons (generic vs reference) were carried out with model-independent and model-dependent approaches. Mean dissolution time and dissolution efficiency were calculated and significant differences, in almost all calculated parameters, were found (p<0.05). Weibull, logistic, Gompertz, and Probit models were used to fit dissolution data and Probit was the best-fit model that describes the in vitro dissolution performance of ACE and CAF. Using t50% data, derived from this fit, dissolution profiles of ACE in USP Apparatus 2 were significant different (p<0.05). The proposed UV derivative method generates reliable information that can be compared with published results. Dissolution studies of fixed-dose combination formulations are important because quality of generic drug products depends on quality of references. It is essential to maintain a post-marketing evaluation of formulations with analgesic drugs mixed with CAF to offer the population high quality medicines.

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