A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines
An accurate and rapid reverse HPLC method has been developed and validated for the simultaneous quantification of lamivudine, nevirapine, and tenofovir disoproxil fumarate. Suitable separation was achieved on Phenomenex Synergi C18 (250 × 4.6 mm, 4 μm) using mobile phase, methanol (50%): ammonium ac...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2020-01-01
|
| Series: | Journal of Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2020/4618360 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849304817159110656 |
|---|---|
| author | Phoebe Esinam Goku Emmanuel Orman Anna Naa Kwarley Quartey Joseph Kwasi Adu Reimmel Kwame Adosraku |
| author_facet | Phoebe Esinam Goku Emmanuel Orman Anna Naa Kwarley Quartey Joseph Kwasi Adu Reimmel Kwame Adosraku |
| author_sort | Phoebe Esinam Goku |
| collection | DOAJ |
| description | An accurate and rapid reverse HPLC method has been developed and validated for the simultaneous quantification of lamivudine, nevirapine, and tenofovir disoproxil fumarate. Suitable separation was achieved on Phenomenex Synergi C18 (250 × 4.6 mm, 4 μm) using mobile phase, methanol (50%): ammonium acetate buffer (adjusted to pH 2.80) (40%): acetonitrile (10%) in an isocratic mode. The drugs were detected at 270 nm with a flow rate of 1.0 ml/min, and the retention times were found to be 3.26, 5.42, and 7.55 minutes for lamivudine, nevirapine, and tenofovir disoproxil fumarate, respectively. The developed method was validated per ICH guidelines. Good linearity was obtained within the concentration ranges of 10–59 µg/ml, 7–42 µg/ml, and 15–90 µg/ml with a correlation coefficient of not less than 0.990. The % RSD values for precision (intraday and interday) and accuracy studies were found to be less than 2%. The results obtained from quantitative analysis conform to USP content requirements for marketed tablet dosage forms, RICOVIR-LN, and tenofovir disoproxil fumarate/lamivudine tablets. The method is therefore useful for routine quality control of antiretroviral tablet dosage forms containing tenofovir disoproxil fumarate, lamivudine, and nevirapine. |
| format | Article |
| id | doaj-art-3cb6490f2ac0464c96482a192534861b |
| institution | Kabale University |
| issn | 2090-9063 2090-9071 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Chemistry |
| spelling | doaj-art-3cb6490f2ac0464c96482a192534861b2025-08-20T03:55:37ZengWileyJournal of Chemistry2090-90632090-90712020-01-01202010.1155/2020/46183604618360A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral MedicinesPhoebe Esinam Goku0Emmanuel Orman1Anna Naa Kwarley Quartey2Joseph Kwasi Adu3Reimmel Kwame Adosraku4Department of Pharmaceutical Sciences, School of Pharmacy, Central University, Accra 23321, GhanaDepartment of Pharmaceutical Chemistry, School of Pharmacy, University of Health and Allied Sciences, Ho 23321, GhanaDepartment of Pharmaceutical Sciences, School of Pharmacy, Central University, Accra 23321, GhanaDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi 23321, GhanaDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi 23321, GhanaAn accurate and rapid reverse HPLC method has been developed and validated for the simultaneous quantification of lamivudine, nevirapine, and tenofovir disoproxil fumarate. Suitable separation was achieved on Phenomenex Synergi C18 (250 × 4.6 mm, 4 μm) using mobile phase, methanol (50%): ammonium acetate buffer (adjusted to pH 2.80) (40%): acetonitrile (10%) in an isocratic mode. The drugs were detected at 270 nm with a flow rate of 1.0 ml/min, and the retention times were found to be 3.26, 5.42, and 7.55 minutes for lamivudine, nevirapine, and tenofovir disoproxil fumarate, respectively. The developed method was validated per ICH guidelines. Good linearity was obtained within the concentration ranges of 10–59 µg/ml, 7–42 µg/ml, and 15–90 µg/ml with a correlation coefficient of not less than 0.990. The % RSD values for precision (intraday and interday) and accuracy studies were found to be less than 2%. The results obtained from quantitative analysis conform to USP content requirements for marketed tablet dosage forms, RICOVIR-LN, and tenofovir disoproxil fumarate/lamivudine tablets. The method is therefore useful for routine quality control of antiretroviral tablet dosage forms containing tenofovir disoproxil fumarate, lamivudine, and nevirapine.http://dx.doi.org/10.1155/2020/4618360 |
| spellingShingle | Phoebe Esinam Goku Emmanuel Orman Anna Naa Kwarley Quartey Joseph Kwasi Adu Reimmel Kwame Adosraku A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines Journal of Chemistry |
| title | A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines |
| title_full | A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines |
| title_fullStr | A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines |
| title_full_unstemmed | A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines |
| title_short | A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines |
| title_sort | simple rp hplc method to simultaneously assay the contents of lamivudine tenofovir and nevirapine in fixed dose combined oral antiviral medicines |
| url | http://dx.doi.org/10.1155/2020/4618360 |
| work_keys_str_mv | AT phoebeesinamgoku asimplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT emmanuelorman asimplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT annanaakwarleyquartey asimplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT josephkwasiadu asimplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT reimmelkwameadosraku asimplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT phoebeesinamgoku simplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT emmanuelorman simplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT annanaakwarleyquartey simplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT josephkwasiadu simplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines AT reimmelkwameadosraku simplerphplcmethodtosimultaneouslyassaythecontentsoflamivudinetenofovirandnevirapineinfixeddosecombinedoralantiviralmedicines |