Pub Date : 2023-01-15DOI: 10.22456/2527-2616.128550
Camila Gomes Carpes, Caroline Venturi, M. Steppe
The analysis of pharmaceuticals is fundamental in both human and veterinary medicine. In this context, quality control must accompany the process from the acquisition of raw material to the transformation into a finished product, since its goal is to ensure safe and effective drugs for human or animal consumption. Considering the significant increase in veterinary prescriptions containing antimicrobial drugs, the present work carried out a search for information about the qualification of veterinary preparations available in the national market, highlighting, through legislation, the quality parameters applied to pharmaceutical products for veterinary use. The quality of solid pharmaceutical preparations containing cephalexin, acquired in the national veterinary pharmaceutical market, was also evaluated. The six different brands of cephalexin tablets and coated tablets analyzed in this study were approved with regard to identification, average weight, determination of mechanical strength in tablets, disintegration test, and content. The results of the determination of the content varied between 94.9% and 103%, being within the limits indicated for preparations for human use, as recommended by USP 44 and the Brazilian Pharmacopeia 6th edition. Even so, it is important to emphasize the need for improvement in the legislation that regulates the quality control of medicines for veterinary use, since the norms are not very specific, with an absence of parameters, specifications, and release procedures that ensure which tests should be performed. This study is a perspective that can bring subsidies for investigations of other therapeutic classes, considering the large number of formulations available in the Brazilian market of veterinary medicines.
{"title":"Quality evaluation of solid pharmaceutical preparations for veterinary use containing cephalexin","authors":"Camila Gomes Carpes, Caroline Venturi, M. Steppe","doi":"10.22456/2527-2616.128550","DOIUrl":"https://doi.org/10.22456/2527-2616.128550","url":null,"abstract":"The analysis of pharmaceuticals is fundamental in both human and veterinary medicine. In this context, quality control must accompany the process from the acquisition of raw material to the transformation into a finished product, since its goal is to ensure safe and effective drugs for human or animal consumption. Considering the significant increase in veterinary prescriptions containing antimicrobial drugs, the present work carried out a search for information about the qualification of veterinary preparations available in the national market, highlighting, through legislation, the quality parameters applied to pharmaceutical products for veterinary use. The quality of solid pharmaceutical preparations containing cephalexin, acquired in the national veterinary pharmaceutical market, was also evaluated. The six different brands of cephalexin tablets and coated tablets analyzed in this study were approved with regard to identification, average weight, determination of mechanical strength in tablets, disintegration test, and content. The results of the determination of the content varied between 94.9% and 103%, being within the limits indicated for preparations for human use, as recommended by USP 44 and the Brazilian Pharmacopeia 6th edition. Even so, it is important to emphasize the need for improvement in the legislation that regulates the quality control of medicines for veterinary use, since the norms are not very specific, with an absence of parameters, specifications, and release procedures that ensure which tests should be performed. This study is a perspective that can bring subsidies for investigations of other therapeutic classes, considering the large number of formulations available in the Brazilian market of veterinary medicines.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"72 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86309192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
For the quantification of ebastine in pharmaceutical suspension, a simple, quick, accurate, and exact stability-indicating HPLC approach was developed and validated. The drug was determined using a phase reverse system and the separation was performed in an analytical C18 column (250 mm x 4.6 mm, 5 μm). The mobile phase consists of 0.1% orthophosphoric acid and methanol in a 25:75, v/v ratio. Using a concentration range of 10–90 μg mL-1, the technique demonstrated a strong linear response (r=0.999). Effluents were measured at 262 nm while the flow rate was kept at 1.0 mL min-1. There was a retention time of 3.506 min. The method was statistically validated to determine its accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity, and forced degradation assessments. The stresses that were used were acid, alkali hydrolysis, water stress, oxidation, photolysis, and heat. Since the degradation products did not affect the capacity to identify ebastine, this technique may be taken as a stability indication. This methodology may be utilized for the analysis of Ebastine in pharmaceutical suspension, since the findings obtained were within the limits set by ICH standards.
建立了一种简便、快速、准确、准确的高效液相色谱法定量测定药物混悬液中埃巴斯汀的方法，并进行了验证。采用反相系统测定药物，分离柱为C18分析柱(250 mm × 4.6 mm, 5 μm)。流动相由0.1%正磷酸和甲醇组成，比例为25:75,v/v。在10 ~ 90 μg mL-1的浓度范围内，该方法具有较强的线性响应(r=0.999)。流速为1.0 mL min-1，流速为262 nm。保留时间为3.506 min。对该方法进行了统计验证，以确定其准确性、精密度、线性度、坚固性、鲁棒性、溶液稳定性、选择性和强制降解评估。所使用的胁迫有酸、碱水解、水胁迫、氧化、光解和热胁迫。由于降解产物不影响鉴定碱性的能力，因此该技术可作为稳定性指标。该方法可用于药物混悬液中埃巴斯丁的分析，因为所获得的结果在ICH标准规定的范围内。
{"title":"Stability-indicating RP-HPLC method applied to the quantification of anti-histaminic drug ebastine in its oral suspension dosage form","authors":"Swathi Koduru, Hemant Kumar Tatapudi, Swathi Kalepu, Chaitanya Mitta, R. Bairam","doi":"10.22456/2527-2616.128122","DOIUrl":"https://doi.org/10.22456/2527-2616.128122","url":null,"abstract":"For the quantification of ebastine in pharmaceutical suspension, a simple, quick, accurate, and exact stability-indicating HPLC approach was developed and validated. The drug was determined using a phase reverse system and the separation was performed in an analytical C18 column (250 mm x 4.6 mm, 5 μm). The mobile phase consists of 0.1% orthophosphoric acid and methanol in a 25:75, v/v ratio. Using a concentration range of 10–90 μg mL-1, the technique demonstrated a strong linear response (r=0.999). Effluents were measured at 262 nm while the flow rate was kept at 1.0 mL min-1. There was a retention time of 3.506 min. The method was statistically validated to determine its accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity, and forced degradation assessments. The stresses that were used were acid, alkali hydrolysis, water stress, oxidation, photolysis, and heat. Since the degradation products did not affect the capacity to identify ebastine, this technique may be taken as a stability indication. This methodology may be utilized for the analysis of Ebastine in pharmaceutical suspension, since the findings obtained were within the limits set by ICH standards.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88640660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-15DOI: 10.22456/2527-2616.128293
Cristiano Da Silva Sousa, L. Mezzomo, J. Butzge, G. Meirelles, S. Bordignon, G. V. von Poser, M. Apel
The essential oils of Salvia ovalifolia, S. procurrens and S. uliginosa were obtained by hydrodistillation and analyzed by gas chromatography-mass spectrometry. The three species displayed very low amounts of essential oils, consisting of a few sesquiterpenes, and aliphatic compounds such as aldehydes and long-chain fatty acids. From the leaves of S. uliginosa, an exudate was obtained which presented the diterpene icetexone as the major component. The exudate and icetexone were evaluated for the activity against Candida species, both showing inhibition of fungal growth.
{"title":"Anti-Candida activity of terpenes from Salvia ovalifolia, S. procurrens and S. uliginosa, native to South Brazil","authors":"Cristiano Da Silva Sousa, L. Mezzomo, J. Butzge, G. Meirelles, S. Bordignon, G. V. von Poser, M. Apel","doi":"10.22456/2527-2616.128293","DOIUrl":"https://doi.org/10.22456/2527-2616.128293","url":null,"abstract":"The essential oils of Salvia ovalifolia, S. procurrens and S. uliginosa were obtained by hydrodistillation and analyzed by gas chromatography-mass spectrometry. The three species displayed very low amounts of essential oils, consisting of a few sesquiterpenes, and aliphatic compounds such as aldehydes and long-chain fatty acids. From the leaves of S. uliginosa, an exudate was obtained which presented the diterpene icetexone as the major component. The exudate and icetexone were evaluated for the activity against Candida species, both showing inhibition of fungal growth.\u0000 \u0000 ","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"65 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86612797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-15DOI: 10.22456/2527-2616.127631
A. Kogawa, H. R. Salgado
Quality control in the chemical-pharmaceutical industry to identify and quantify the active ingredient has fundamental importance to guarantee the quality of the final product. Its lack can generate irreparable consequences, and therefore its existence is extremely important. However, currently, in this process there is an ecologically correct need beyond the choice of the ideal method and the ideal conditions. This mini-review contemplates the current technological vision of pharmaceutical analysis through Green Analytical Chemistry (GAC). Green and sustainable methods have a main focus providing economic, environmental and social benefits. An example is spectrophotometry in the infrared region for quantitative purposes. The purpose of this mini-review is to show a practical guide for the quantitative analysis of raw materials and pharmaceutical products by spectrophotometry in the infrared region in order to contribute to a sustainability cycle, where the guarantee of product quality and the analytical awareness about health, time, waste generation, environment and cost coexist. A practical review for quantitative analysis by spectrophotometry in the infrared region was shown. It is useful for routine analysis of pharmaceutical products in general, and it can be used by chemical-pharmaceutical laboratories around the world.
{"title":"Quantitative analysis of pharmaceutical products by spectrophotometry in the infrared region: a practical review","authors":"A. Kogawa, H. R. Salgado","doi":"10.22456/2527-2616.127631","DOIUrl":"https://doi.org/10.22456/2527-2616.127631","url":null,"abstract":"Quality control in the chemical-pharmaceutical industry to identify and quantify the active ingredient has fundamental importance to guarantee the quality of the final product. Its lack can generate irreparable consequences, and therefore its existence is extremely important. However, currently, in this process there is an ecologically correct need beyond the choice of the ideal method and the ideal conditions. This mini-review contemplates the current technological vision of pharmaceutical analysis through Green Analytical Chemistry (GAC). Green and sustainable methods have a main focus providing economic, environmental and social benefits. An example is spectrophotometry in the infrared region for quantitative purposes. The purpose of this mini-review is to show a practical guide for the quantitative analysis of raw materials and pharmaceutical products by spectrophotometry in the infrared region in order to contribute to a sustainability cycle, where the guarantee of product quality and the analytical awareness about health, time, waste generation, environment and cost coexist. A practical review for quantitative analysis by spectrophotometry in the infrared region was shown. It is useful for routine analysis of pharmaceutical products in general, and it can be used by chemical-pharmaceutical laboratories around the world.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"56 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83869743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-28DOI: 10.22456/2527-2616.120940
Paulo Roberto Rodrigues Martini, Douglas Dos Santos Porto, Paola Ribeiro Motta, Lisiane Bajerski, Marcelo Donadel Malesuik, Clésio Soldateli Paim
This study describes the development and validation of a new environmentally friendly analytical method for the determination of bilastine in coated tablets and the evaluation of its capacity to be stability-indicating as well. The ecofriendly analytical method was validated by specificity, linearity, accuracy, precision and robustness by reversed-phase high-performance liquid chromatography (RP-HPLC) according to International Conference on Harmonization guidelines (ICH) and Association of Official Analytical Chemists (AOAC). Isocratic LC separation was achieved on a RP18 column using a mobile phase of sodium dihydrogen phosphate aqueous buffer solution adjusted to pH (6.0 ± 0.1) with o-phosphoric acid (85% v/v) and triethylamine (0,3% v/v) and ethanol (EtOH) in the following proportions (60:40 v/v), at a flow rate of 1.0 mL·min-1 at temperature-controlled at 30 °C. The analytical method showed selectivity, good recovery and precision (intra- and inter-day), robustness, and linear over a range from 5.0 to 50 μg·mL-1.
{"title":"Bilastine: stability-indicating a method using environmentally friendly by reversed-phase high-performance liquid chromatography (RP-HPLC)","authors":"Paulo Roberto Rodrigues Martini, Douglas Dos Santos Porto, Paola Ribeiro Motta, Lisiane Bajerski, Marcelo Donadel Malesuik, Clésio Soldateli Paim","doi":"10.22456/2527-2616.120940","DOIUrl":"https://doi.org/10.22456/2527-2616.120940","url":null,"abstract":"This study describes the development and validation of a new environmentally friendly analytical method for the determination of bilastine in coated tablets and the evaluation of its capacity to be stability-indicating as well. The ecofriendly analytical method was validated by specificity, linearity, accuracy, precision and robustness by reversed-phase high-performance liquid chromatography (RP-HPLC) according to International Conference on Harmonization guidelines (ICH) and Association of Official Analytical Chemists (AOAC). Isocratic LC separation was achieved on a RP18 column using a mobile phase of sodium dihydrogen phosphate aqueous buffer solution adjusted to pH (6.0 ± 0.1) with o-phosphoric acid (85% v/v) and triethylamine (0,3% v/v) and ethanol (EtOH) in the following proportions (60:40 v/v), at a flow rate of 1.0 mL·min-1 at temperature-controlled at 30 °C. The analytical method showed selectivity, good recovery and precision (intra- and inter-day), robustness, and linear over a range from 5.0 to 50 μg·mL-1.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89425927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-28DOI: 10.22456/2527-2616.122299
T. M. Ciocheta, Aline de Cristo Soares Alves, D. R. Dallemole, R. Cé, Silvia Stanisçuaski Guterres, Adriana Raffin Pohlmann
We developed a solid formulation of calcium alginate beads containing paclitaxel-loaded lipid-core nanocapsules (PTX-LNC-Bead) intended for oral administration. The PTX-LNC liquid formulation was prepared by interfacial deposition and trapped into calcium alginate beads. These beads were characterized in terms of size, morphology, swelling rate, encapsulation efficiency, and release of PTX and LNC in simulated gastrointestinal fluids. Results showed that the beads were gastro-resistant with low swelling rate and drug release lower than 3.5% at pH 1.2 (2h). At pH 6.8, the beads showed high swelling rate and disintegration after 80 min. Drug release was 60% after 600 min. Particle sizing as a function of time confirmed that LNC were released intact from the beads at pH 6.8 showing that PTX-LNC-Bead is a promising product for PTX oral administration. Our results pave the way for novel formulations intended for drug targeting by the oral route.
{"title":"Development of calcium alginate beads containing paclitaxel-loaded lipid-core nanocapsules intended for oral administration","authors":"T. M. Ciocheta, Aline de Cristo Soares Alves, D. R. Dallemole, R. Cé, Silvia Stanisçuaski Guterres, Adriana Raffin Pohlmann","doi":"10.22456/2527-2616.122299","DOIUrl":"https://doi.org/10.22456/2527-2616.122299","url":null,"abstract":"We developed a solid formulation of calcium alginate beads containing paclitaxel-loaded lipid-core nanocapsules (PTX-LNC-Bead) intended for oral administration. The PTX-LNC liquid formulation was prepared by interfacial deposition and trapped into calcium alginate beads. These beads were characterized in terms of size, morphology, swelling rate, encapsulation efficiency, and release of PTX and LNC in simulated gastrointestinal fluids. Results showed that the beads were gastro-resistant with low swelling rate and drug release lower than 3.5% at pH 1.2 (2h). At pH 6.8, the beads showed high swelling rate and disintegration after 80 min. Drug release was 60% after 600 min. Particle sizing as a function of time confirmed that LNC were released intact from the beads at pH 6.8 showing that PTX-LNC-Bead is a promising product for PTX oral administration. Our results pave the way for novel formulations intended for drug targeting by the oral route.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77315948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The biological/pharmacological activities of any herbal drug are determined by the bioactive components contained in the plant(s) used in its formulation, these substances are greatly affected by the quality control system adopted during and after production processes and handling of such product. Thin Layer Chromatography is one of such quality control parameters that demonstrate uniqueness and uniformity between various substances, thus serving as an identity for such products. Pax Herbal Malatreat tea is a polyherbal drug used in the management and treatment of malaria symptoms. This study evaluated the different phytoconstituents present and developed fingerprint profiles (TLC) for the drug (Pax Herbal Malatreat Tea) to serve as a quality control check during the production consistency and market uniqueness. Qualitative phytochemical and chromatographic analyses were carried out using standard methods. The qualitative test revealed the presence of Tannin, Flavonoid, Saponin, Steroids, Reducing sugar, and Terpenoids, and the finger-print chromatograms after development with chloroform-ethyl acetate (9.5:05) showed five distinct components at 365 nm and four spots when sprayed with 20% methanolic sulphuric acid and viewed under visible light. From this present report, an identity card has been developed for the drug (Pax Herbal Malatreat Tea) via bioactive composition and TLC profiles which can be used in accessing the quality and consistency of the product.
{"title":"Bioactive composition and TLC profile data on Pax Herbal Malatreat Tea","authors":"Tunde Ayobami Owolabi, Dominion Osaretin, Blessing Eyinayan","doi":"10.22456/2527-2616.125038","DOIUrl":"https://doi.org/10.22456/2527-2616.125038","url":null,"abstract":"The biological/pharmacological activities of any herbal drug are determined by the bioactive components contained in the plant(s) used in its formulation, these substances are greatly affected by the quality control system adopted during and after production processes and handling of such product. Thin Layer Chromatography is one of such quality control parameters that demonstrate uniqueness and uniformity between various substances, thus serving as an identity for such products. Pax Herbal Malatreat tea is a polyherbal drug used in the management and treatment of malaria symptoms. This study evaluated the different phytoconstituents present and developed fingerprint profiles (TLC) for the drug (Pax Herbal Malatreat Tea) to serve as a quality control check during the production consistency and market uniqueness. Qualitative phytochemical and chromatographic analyses were carried out using standard methods. The qualitative test revealed the presence of Tannin, Flavonoid, Saponin, Steroids, Reducing sugar, and Terpenoids, and the finger-print chromatograms after development with chloroform-ethyl acetate (9.5:05) showed five distinct components at 365 nm and four spots when sprayed with 20% methanolic sulphuric acid and viewed under visible light. From this present report, an identity card has been developed for the drug (Pax Herbal Malatreat Tea) via bioactive composition and TLC profiles which can be used in accessing the quality and consistency of the product.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90353454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-28DOI: 10.22456/2527-2616.125170
Dipika Solanki, D. Patel, D. Meshram
Efonidipine Hydrochloride Ethanolate and Chlorthalidone is used in management of hypertension and under clinical phase 3 study. The development of quality control method is required for accurate analysis of both drugs. Two simple, precise and economical UV spectrophotometric methods have been developed for the simultaneous estimation of Efonidipine Hydrochloride Ethanolate and Chlorthalidone in their synthetic mixture. Method I is simultaneous equation method (Vierodt’s Method), which is based on measurement of absorption at 251 and 227 nm i.e. λmax of Efonidipine Hydrochloride Ethanolate and Chlorthalidone, respectively. Method II is first order derivative was based on the measurement of absorbance of Efonidipine Hydrochloride Ethanolate measure at 283.2 nm (ZCP of Chlorthalidone) and absorbance of Chlorthalidone measure at 250.8 nm (ZCP of Efonidipine Hydrochloride Ethanolate). Linearity was observed in the concentration range of 6.4-38.4 µg.mL-1 for Efonidipine hydrochloride ethanolate and 2-12 µg.mL-1 for Chlorthalidone using methanol as a solvent. The accuracy of methods was assessed by recovery studies and was found to be within range of 98-102% for both the drugs. Precision of the methods was estimated by repeatability and intermediate precision studies. The % RSD values were found to be less than 2, proving methods were precise. Two methods were compared using F- test. The results were validated statistically as per ICH Q2 R1 guideline and were found to be satisfactory.
{"title":"Development and validation of UV Spectrophotometric method for simultaneous estimation of Efonidipine hydrochloride ethanolate and Chlorthalidone in their synthetic mixture","authors":"Dipika Solanki, D. Patel, D. Meshram","doi":"10.22456/2527-2616.125170","DOIUrl":"https://doi.org/10.22456/2527-2616.125170","url":null,"abstract":"Efonidipine Hydrochloride Ethanolate and Chlorthalidone is used in management of hypertension and under clinical phase 3 study. The development of quality control method is required for accurate analysis of both drugs. Two simple, precise and economical UV spectrophotometric methods have been developed for the simultaneous estimation of Efonidipine Hydrochloride Ethanolate and Chlorthalidone in their synthetic mixture. Method I is simultaneous equation method (Vierodt’s Method), which is based on measurement of absorption at 251 and 227 nm i.e. λmax of Efonidipine Hydrochloride Ethanolate and Chlorthalidone, respectively. Method II is first order derivative was based on the measurement of absorbance of Efonidipine Hydrochloride Ethanolate measure at 283.2 nm (ZCP of Chlorthalidone) and absorbance of Chlorthalidone measure at 250.8 nm (ZCP of Efonidipine Hydrochloride Ethanolate). Linearity was observed in the concentration range of 6.4-38.4 µg.mL-1 for Efonidipine hydrochloride ethanolate and 2-12 µg.mL-1 for Chlorthalidone using methanol as a solvent. The accuracy of methods was assessed by recovery studies and was found to be within range of 98-102% for both the drugs. Precision of the methods was estimated by repeatability and intermediate precision studies. The % RSD values were found to be less than 2, proving methods were precise. Two methods were compared using F- test. The results were validated statistically as per ICH Q2 R1 guideline and were found to be satisfactory.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75422273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-28DOI: 10.22456/2527-2616.125327
Paola De Souza Sanches, Laila Michalski de Oliveira Peixoto, Thamyres Conti dos Santos, Carina Quintanilha da Silva, Gabriela Baptista Brito, Yasmim Da Silva Flores, Natália Farias Santos, Emeli Moura de Araújo, Samanta Cardozo Mourão, Deborah Quintanilha Falcão
This study aimed to evaluate the influence of the grape seed oil (GSO) on the sun protection factor (SPF) of sunscreen emulsified formulations containing butyl methoxydibenzoylmethane (avobenzone (AVO)) and octyl methoxycinnamate (OMC) developed by phase inversion temperature (PIT) employing a Central Composite Design. Formulations were prepared by PIT emulsification process. Seventeen emulsions containing different amounts of GSO, AVO and OMC were obtained according to experimental design. In vitro SPF was determined using a spectrophotometric method. As expected, formulations with the highest concentrations of UV filters, AVO and OMC, resulted in the highest SPF values, while the lowest SPF values were obtained by formulations containing concentrations of these filters below the central point. In the tested concentrations, the variable OMC and its combination with GSO showed to influence the SPF linearly as a function of their concentrations in formulations. The combination of GSO with OMC contributed to increase in vitro SPF. The use of natural compounds with antioxidant activity, such as GSO, is a viable strategy to increase the effectiveness of sunscreens to protect the human skin against UV-induced damage.
{"title":"Influence of grape seed oil on sun protection factor in sunscreen formulations: a study using Central Composite Design approach","authors":"Paola De Souza Sanches, Laila Michalski de Oliveira Peixoto, Thamyres Conti dos Santos, Carina Quintanilha da Silva, Gabriela Baptista Brito, Yasmim Da Silva Flores, Natália Farias Santos, Emeli Moura de Araújo, Samanta Cardozo Mourão, Deborah Quintanilha Falcão","doi":"10.22456/2527-2616.125327","DOIUrl":"https://doi.org/10.22456/2527-2616.125327","url":null,"abstract":"This study aimed to evaluate the influence of the grape seed oil (GSO) on the sun protection factor (SPF) of sunscreen emulsified formulations containing butyl methoxydibenzoylmethane (avobenzone (AVO)) and octyl methoxycinnamate (OMC) developed by phase inversion temperature (PIT) employing a Central Composite Design. Formulations were prepared by PIT emulsification process. Seventeen emulsions containing different amounts of GSO, AVO and OMC were obtained according to experimental design. In vitro SPF was determined using a spectrophotometric method. As expected, formulations with the highest concentrations of UV filters, AVO and OMC, resulted in the highest SPF values, while the lowest SPF values were obtained by formulations containing concentrations of these filters below the central point. In the tested concentrations, the variable OMC and its combination with GSO showed to influence the SPF linearly as a function of their concentrations in formulations. The combination of GSO with OMC contributed to increase in vitro SPF. The use of natural compounds with antioxidant activity, such as GSO, is a viable strategy to increase the effectiveness of sunscreens to protect the human skin against UV-induced damage.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":"127 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84441896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-28DOI: 10.22456/2527-2616.124882
J. Dos Santos, Rebeca Lino Lourenço, P. Rosa, A. I. Adams
N',N'-diethyl-m-toluamide (DEET) is the repellent most commonly used against mosquito vectors of diseases such as dengue, yellow fever and chikungunya. In Brazil, DEET is marketed in aerosol, solution, lotion and gel forms, at concentrations ranging from 6.65 to 25%. In this study, the kinetic degradation under UVC radiation was studied, as well as the penetration/permeation and the ocular irritant potential of DEET repellents in the form of solution, lotion and gel. The photostability study was conducted over 96h, and the DEET degradation kinetics under UVC radiation was fitted to the zero-order model for the three formulations; t90% values of 23.7 h, 17.0 h and 16.1 h were obtained for gel, lotion and solution forms, respectively. The in vitro skin penetration/permeation using the vertical Franz cell in pig skin showed that all the formulations penetrated/permeated the skin layers, at a higher rate when the lotion (p<0.05) was used, possibly due to its qualitative composition. The in vitro ocular irritant potential using the HET-CAM method indicated that one of the products evaluated was classified as "moderate irritant" and five as "severe irritant”. The set of data indicated the lower penetration/permeation of the solution form and reinforces the importance of being careful during application, to avoid accidental contact with the eyes.
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