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Yıl 2022, Cilt: 26 Sayı: 6, 1694 - 1702, 28.06.2025

Viviane Annisa , Teuku Nanda Syaifullah Sulaiman , Akhmad Kharis Nugroho , Agung Endro Nugroho

https://doi.org/10.29228/jrp.260
Cited By: 2

Öz

Kaynakça

  • [1] Kedor-Hackmann ERM, Santoro MIRM, Singh AK, Peraro AC. First-Derivative Ultraviolet Spectrophotometric and High Performance Liquid Chromatographic Determination of Ketoconazole in Pharmaceutical Emulsions. Rev Bras Ciencias Farm J Pharm Sci. 2006;42(1):91–98.
  • [2] Jouyban-Gharamaleki V, Jouyban A, Zhao H, Martinez F, Rahimpour E. Solubility Study of Ketoconazole in Propylene Glycol and Ethanol Mixtures at Different Temperatures: A Laser Monitoring Method. J Mol Liq. 2021;337:1–6. [CrossRef]
  • [3] Zhou R, Moench P, Heran C, Lu X, Mathias N, Faria TN, Wall DA, Hussain MA, Smith RL, Sun D. PH-Dependent Dissolution in Vitro and Absorption in Vivo of Weakly Basic Drugs: Development of a Canine Model. Pharm Res. 2005;22(2):188–192. [CrossRef]
  • [4] Vertzoni M, Pastelli E, Psachoulias D, Kalantzi L, Reppas C. Estimation of Intragastric Solubility of Drugs: In What Medium? Pharm Res. 2007;24(5):909–917. [CrossRef]
  • [5] Hamed R, Awadallah A, Sunoqrot S, Tarawneh O, Nazzal S, AlBaraghthi T, Al Sayyad J, Abbas A. PH-Dependent Solubility and Dissolution Behavior of Carvedilol—Case Example of a Weakly Basic BCS Class II Drug. AAPS PharmSciTech. 2016;17(2):418–426. [CrossRef]
  • [6] Shah HS, Sardhara R, Nahar K, Xu T, Delvadia P, Siddiqui A, Gao Z, Selen A, Morris K. Development and Validation of Sample Preparation and an HPLC Analytical Method for Dissolution Testing in Fed-State Simulated Gastric Fluid—Illustrating Its Application for Ibuprofen and Ketoconazole Immediate Release Tablets. AAPS PharmSciTech. 2020;21(5):1–13. [CrossRef]
  • [7] Jouyban-Gharamaleki V, Jouyban A, Martinez F, Zhao H, Rahimpour E. A Laser Monitoring Technique for Solubility Study of Ketoconazole in Propylene Glycol and 2-Propanol Mixtures at Various Temperatures. J Mol Liq. 2020;320:1–5. [CrossRef]
  • [8] Marcelín-Jiménez G, Hernández J, Ángeles AP, Contreras L, Hinojosa M, Rivera L, Martínez-Rossier L, Amancio O, Fernández A. Bioequivalence Evaluation of Two Brands of Ketoconazole Tablets (Onofin-K® and Nizoral®) in a Healthy Female Mexican Population. Biopharm Drug Dispos. 2004;25(5):203–209. [CrossRef]
  • [9] Sharma S, Gyan S, Univeristy V. Development and Validation Of Reverse-Phase HPLC Method For Estimation of Ketoconazole In Bulk Drug. Pharmacophore. 2012;3(2):123–129. [CrossRef]
  • [10] Shrivastava S, Shrivastava S, Tiwle R. Validation of Novel UV Spectrophotometric Method for the Determination of Ketoconazole in Pharmaceutical Formulation. J Pharm Adv Res. 2020;3(2):792–798.
  • [11] Kansagra P, Sanghvi G, Purohit P, Vachani A, Sheth N, Vaishnav D. Development and Validation of Stability Indicating UV Spectrophotometric Method for the Determination of Ketoconazole Both in Bulk and Marketed Dosage Formulation. Pharm Anal Qual Assur. 2013;2013(1):1–5. [CrossRef]
  • [12] Popovska O, Kavrakovski Z, Rafajlovska V. Development and Validation of UV Spectroscopic Method For Determination of Ketoconazole In Pharmaceutical Formulations. Int J Pharm. 2014;4(4):95–101.
  • [13] Saez V, Freitas JM, Hernández JR, Regina Elias Mansur C. Validation of UV Spectrophotometric Method for Quantifying Ketoconazole Encapsulated in Ethyl Cellulose Microspheres. Macromol Symp. 2018;380(1):1–6. [CrossRef]
  • [14] Sane R, Tendolkar R, Gangal D, Kothurkar R. An Extractive Colorimetric Method for the Determination of Ketoconazole from Pharmaceutical Preparations. Indian J Pharm. 1988;50:347–348.
  • [15] Shamsipur M, Farhadi K. Adsorptive Stripping Voltammetric Determination of Ketoconazole in Pharmaceutical Preparations and Urine Using Carbon Paste Electrodes. Analyst. 2000;125(9):1639–1643. [CrossRef]
  • [16] Low AS, Wangboonskul J. An HPLC Assay for the Determination of Ketoconazole in Common Pharmaceutical Preparations. Analyst. 1999;124(11):1589–1593. [CrossRef]
  • [17] Mendez ASL, Steppe M, Schapoval EES. Validation of HPLC and UV Spectrophotometric Methods for the Determination of Meropenem in Pharmaceutical Dosage Form. J Pharm Biomed Anal. 2003;33(5):947–954. [CrossRef]
  • [18] Hurtado FK, Nogueira DR, Bortolini F, da Silva LM, Zimmermann E, e Souza MJ, de Melo J, Bueno Rolim CM. Determination of Levofloxacin in a Pharmaceutical Injectable Formulation by Using HPLC and UV Spectrophotometric Methods. J Liq Chromatogr Relat Technol. 2007;30(13):1981–1989. [CrossRef]
  • [19] Soderlind E, Karlsson E, Carlsson A, Kong R, Lenz A, Lindborg S, Sheng JJ. Simulating Fasted Human Intestinal Fluids: Understanding the Roles of Lecithin and Bile Acids. Mol Pharm. 2010;7(5):1498–1507. [CrossRef]
  • [20] Murnane D, Martin GP, Marriott C. Validation of a Reverse-Phase High Performance Liquid Chromatographic Method for Concurrent Assay of a Weak Base (Salmeterol Xinafoate) and a Pharmacologically Active Steroid (Fluticasone Propionate). J Pharm Biomed Anal. 2006;40(5):1149–1154. [CrossRef]
  • [21] USP. The United States Pharmacopeial Convention. In: United States Pharmacopeial Conv. USA: USP; 2011; 711.
  • [22] Adachi M, Hinatsu Y, Kusamori K, Katsumi H, Sakane T, Nakatani M, Wada K, Yamamoto A. Improved Dissolution and Absorption of Ketoconazole in the Presence of Organic Acids as PH-Modifiers. Eur J Pharm Sci. 2015;76:225–230. [CrossRef]
  • [23] Fung M, Bērziņš K, Suryanarayanan R. Physical Stability and Dissolution Behavior of Ketoconazole-Organic Acid Coamorphous Systems. Mol Pharm. 2018;15(5):1862–1869. [CrossRef]
  • [24] Ullrich A, Schiffter HA. The Influence of Polymer Excipients on the Dissolution and Recrystallization Behavior of Ketoconazole: Application, Variation and Practical Aspects of a PH Shift Method. Eur J Pharm Biopharm. 2018;133:20–30. [CrossRef]
  • [25] Kumar P, Mohan C, Kanam M, Uma S, Gulati M. Physiochemical Characterization and Release Rate Studies of Solid Dispersions of Ketoconazole with Pluronic F127 and PVP K-30. 2011;10(November 2009):685–694.
  • [26] Jandera P. Stationary and Mobile Phases in Hydrophilic Interaction Chromatography: A Review. Anal Chim Acta. 2011;692(1–2):1–25. [CrossRef]
  • [27] Rosés M, Bosch E. Influence of Mobile Phase Acid-Base Equilibria on the Chromatographic Behaviour of Protolytic Compounds. J Chromatogr A. 2002;982(1):1–30. [CrossRef]
  • [28] Sousa J, Alves G, Fortuna A, Falcão A. Analytical Methods for Determination of New Fluoroquinolones in Biological Matrices and Pharmaceutical Formulations by Liquid Chromatography: A Review. Anal Bioanal Chem. 2012;403(1):93–129. [CrossRef]
  • [29] Roos RW, Lau-Cam CA. General Reversed-Phase High-Performance Liquid Chromatographic Method for the Separation of Drugs Using Triethylamine as a Competing Base. J Chromatogr A. 1986;370(C):403–418. [CrossRef]
  • [30] Thompson M, Ellison SLR, Wood R. Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis (IUPAC Technical Report). Pure Appl Chem. 2002;74(5):835–855.
  • [31] EMA. Validation of Analytical Procedures: Text and Methodology. London: European Medicines Agency; 1995.
  • [32] WHO. Guidelines on Validation – Appendix 4 Analytical Method Validation. Switzerland: World Health Organization; 2016.
  • [33] AOAC. Standard Format and Guidance for AOAC Standard Method Performance Requirement (SMPR) Documents. AOAC 2011:1–27.
  • [34] Rozet E, Ceccato A, Hubert C, Ziemons E, Oprean R, Rudaz S, Boulanger B, Hubert P. Analysis of Recent Pharmaceutical Regulatory Documents on Analytical Method Validation. J Chromatogr A. 2007;1158(1–2):111–125. [CrossRef]
  • [35] Gad SC, Levin S. High Performance Liquid Chromatography (HPLC) in the Pharmaceutical Analysis. 2010. [CrossRef]
  • [36] Amrutiya N, Madan M, Bajaj A. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Prednicarbate, Mupirocin and Ketoconazole in Topical Dosage Forms. J Anal Chem. 2010;65(11):1148–1154. [CrossRef]
  • [37] Avdeef A. Solubility of Sparingly-Soluble Ionizable Drugs. Adv Drug Deliv Rev. 2007;59(7):568–590. [CrossRef]
  • [38] Basheer L, Schultz K, Fichman M, Kerem Z. Use of in Vitro and Predictive in Silico Models to Study the Inhibition of Cytochrome P4503A by Stilbenes. PLoS One. 2015;10(10):1–17. [CrossRef]
  • [39] Baka E, Comer JEA, Takács-Novák K. Study of Equilibrium Solubility Measurement by Saturation Shake-Flask Method Using Hydrochlorothiazide as Model Compound. J Pharm Biomed Anal. 2008;46(2):335–341. [CrossRef]
  • [40] PubChem. Ketoconazole. https://pubchem.ncbi.nlm.nih.gov/compound/Ketoconazole (accessed on 23 May 2022)

Validation of RP-HPLC method for determination of pHdependent solubility of ketoconazole in phosphate buffer pH 6.8

Yıl 2022, Cilt: 26 Sayı: 6, 1694 - 1702, 28.06.2025

Viviane Annisa , Teuku Nanda Syaifullah Sulaiman , Akhmad Kharis Nugroho , Agung Endro Nugroho

https://doi.org/10.29228/jrp.260
Cited By: 2

Öz

The solubility of ketoconazole is highly dependent on the pH of the medium. Solubility is an important physicochemical parameter needed to consider and predict to obtain the drug behavior in a physiological environment. Determination of solubility of ketoconazole in pH of intestine fluid (6-7.4) is not easy due to ketoconazole poor soluble in intestine fluid pH. The aim of this study was to validate an assay for the solubility of ketoconazole in phosphate buffer pH 6.8 using the RP-HPLC method. In addition to representing intestinal pH, phosphate buffer pH 6.8 is also generally used as an alkaline medium for the dissolution testing of several drugs. The method to analyze the solubility of ketoconazole has been developed and validated. The method was used an isocratic Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) using Phenomenex Luna (250 x 4.6 mm, 5 µm) column with a mobile phase consisting of acetonitrile: water with TEA 0.15% pH 3.3 in ratio 50:50, at the flow rate of 1 mL/min and UV detection at wavelength 232 nm. The correlation coefficients were obtained at r2=0.9997 in the range of 0.5-12 µg/mL. The recovery % ranged within 100-101%. The intra and interday RSD% were less than 1.74%. LoD was 0.15 µg/mL and LoQ was 0.45 µg/mL. According to ICH guidelines, the method was validated for selectivity, linearity, accuracy, precision, LoQ, and LoD. The proposed method is suitable for determining the solubility of ketoconazole in phosphate buffer pH 6.8.

Anahtar Kelimeler

Solubility determination ketoconazole analysis HPLC method validation phosphate buffer shake flask

Kaynakça

  • [1] Kedor-Hackmann ERM, Santoro MIRM, Singh AK, Peraro AC. First-Derivative Ultraviolet Spectrophotometric and High Performance Liquid Chromatographic Determination of Ketoconazole in Pharmaceutical Emulsions. Rev Bras Ciencias Farm J Pharm Sci. 2006;42(1):91–98.
  • [2] Jouyban-Gharamaleki V, Jouyban A, Zhao H, Martinez F, Rahimpour E. Solubility Study of Ketoconazole in Propylene Glycol and Ethanol Mixtures at Different Temperatures: A Laser Monitoring Method. J Mol Liq. 2021;337:1–6. [CrossRef]
  • [3] Zhou R, Moench P, Heran C, Lu X, Mathias N, Faria TN, Wall DA, Hussain MA, Smith RL, Sun D. PH-Dependent Dissolution in Vitro and Absorption in Vivo of Weakly Basic Drugs: Development of a Canine Model. Pharm Res. 2005;22(2):188–192. [CrossRef]
  • [4] Vertzoni M, Pastelli E, Psachoulias D, Kalantzi L, Reppas C. Estimation of Intragastric Solubility of Drugs: In What Medium? Pharm Res. 2007;24(5):909–917. [CrossRef]
  • [5] Hamed R, Awadallah A, Sunoqrot S, Tarawneh O, Nazzal S, AlBaraghthi T, Al Sayyad J, Abbas A. PH-Dependent Solubility and Dissolution Behavior of Carvedilol—Case Example of a Weakly Basic BCS Class II Drug. AAPS PharmSciTech. 2016;17(2):418–426. [CrossRef]
  • [6] Shah HS, Sardhara R, Nahar K, Xu T, Delvadia P, Siddiqui A, Gao Z, Selen A, Morris K. Development and Validation of Sample Preparation and an HPLC Analytical Method for Dissolution Testing in Fed-State Simulated Gastric Fluid—Illustrating Its Application for Ibuprofen and Ketoconazole Immediate Release Tablets. AAPS PharmSciTech. 2020;21(5):1–13. [CrossRef]
  • [7] Jouyban-Gharamaleki V, Jouyban A, Martinez F, Zhao H, Rahimpour E. A Laser Monitoring Technique for Solubility Study of Ketoconazole in Propylene Glycol and 2-Propanol Mixtures at Various Temperatures. J Mol Liq. 2020;320:1–5. [CrossRef]
  • [8] Marcelín-Jiménez G, Hernández J, Ángeles AP, Contreras L, Hinojosa M, Rivera L, Martínez-Rossier L, Amancio O, Fernández A. Bioequivalence Evaluation of Two Brands of Ketoconazole Tablets (Onofin-K® and Nizoral®) in a Healthy Female Mexican Population. Biopharm Drug Dispos. 2004;25(5):203–209. [CrossRef]
  • [9] Sharma S, Gyan S, Univeristy V. Development and Validation Of Reverse-Phase HPLC Method For Estimation of Ketoconazole In Bulk Drug. Pharmacophore. 2012;3(2):123–129. [CrossRef]
  • [10] Shrivastava S, Shrivastava S, Tiwle R. Validation of Novel UV Spectrophotometric Method for the Determination of Ketoconazole in Pharmaceutical Formulation. J Pharm Adv Res. 2020;3(2):792–798.
  • [11] Kansagra P, Sanghvi G, Purohit P, Vachani A, Sheth N, Vaishnav D. Development and Validation of Stability Indicating UV Spectrophotometric Method for the Determination of Ketoconazole Both in Bulk and Marketed Dosage Formulation. Pharm Anal Qual Assur. 2013;2013(1):1–5. [CrossRef]
  • [12] Popovska O, Kavrakovski Z, Rafajlovska V. Development and Validation of UV Spectroscopic Method For Determination of Ketoconazole In Pharmaceutical Formulations. Int J Pharm. 2014;4(4):95–101.
  • [13] Saez V, Freitas JM, Hernández JR, Regina Elias Mansur C. Validation of UV Spectrophotometric Method for Quantifying Ketoconazole Encapsulated in Ethyl Cellulose Microspheres. Macromol Symp. 2018;380(1):1–6. [CrossRef]
  • [14] Sane R, Tendolkar R, Gangal D, Kothurkar R. An Extractive Colorimetric Method for the Determination of Ketoconazole from Pharmaceutical Preparations. Indian J Pharm. 1988;50:347–348.
  • [15] Shamsipur M, Farhadi K. Adsorptive Stripping Voltammetric Determination of Ketoconazole in Pharmaceutical Preparations and Urine Using Carbon Paste Electrodes. Analyst. 2000;125(9):1639–1643. [CrossRef]
  • [16] Low AS, Wangboonskul J. An HPLC Assay for the Determination of Ketoconazole in Common Pharmaceutical Preparations. Analyst. 1999;124(11):1589–1593. [CrossRef]
  • [17] Mendez ASL, Steppe M, Schapoval EES. Validation of HPLC and UV Spectrophotometric Methods for the Determination of Meropenem in Pharmaceutical Dosage Form. J Pharm Biomed Anal. 2003;33(5):947–954. [CrossRef]
  • [18] Hurtado FK, Nogueira DR, Bortolini F, da Silva LM, Zimmermann E, e Souza MJ, de Melo J, Bueno Rolim CM. Determination of Levofloxacin in a Pharmaceutical Injectable Formulation by Using HPLC and UV Spectrophotometric Methods. J Liq Chromatogr Relat Technol. 2007;30(13):1981–1989. [CrossRef]
  • [19] Soderlind E, Karlsson E, Carlsson A, Kong R, Lenz A, Lindborg S, Sheng JJ. Simulating Fasted Human Intestinal Fluids: Understanding the Roles of Lecithin and Bile Acids. Mol Pharm. 2010;7(5):1498–1507. [CrossRef]
  • [20] Murnane D, Martin GP, Marriott C. Validation of a Reverse-Phase High Performance Liquid Chromatographic Method for Concurrent Assay of a Weak Base (Salmeterol Xinafoate) and a Pharmacologically Active Steroid (Fluticasone Propionate). J Pharm Biomed Anal. 2006;40(5):1149–1154. [CrossRef]
  • [21] USP. The United States Pharmacopeial Convention. In: United States Pharmacopeial Conv. USA: USP; 2011; 711.
  • [22] Adachi M, Hinatsu Y, Kusamori K, Katsumi H, Sakane T, Nakatani M, Wada K, Yamamoto A. Improved Dissolution and Absorption of Ketoconazole in the Presence of Organic Acids as PH-Modifiers. Eur J Pharm Sci. 2015;76:225–230. [CrossRef]
  • [23] Fung M, Bērziņš K, Suryanarayanan R. Physical Stability and Dissolution Behavior of Ketoconazole-Organic Acid Coamorphous Systems. Mol Pharm. 2018;15(5):1862–1869. [CrossRef]
  • [24] Ullrich A, Schiffter HA. The Influence of Polymer Excipients on the Dissolution and Recrystallization Behavior of Ketoconazole: Application, Variation and Practical Aspects of a PH Shift Method. Eur J Pharm Biopharm. 2018;133:20–30. [CrossRef]
  • [25] Kumar P, Mohan C, Kanam M, Uma S, Gulati M. Physiochemical Characterization and Release Rate Studies of Solid Dispersions of Ketoconazole with Pluronic F127 and PVP K-30. 2011;10(November 2009):685–694.
  • [26] Jandera P. Stationary and Mobile Phases in Hydrophilic Interaction Chromatography: A Review. Anal Chim Acta. 2011;692(1–2):1–25. [CrossRef]
  • [27] Rosés M, Bosch E. Influence of Mobile Phase Acid-Base Equilibria on the Chromatographic Behaviour of Protolytic Compounds. J Chromatogr A. 2002;982(1):1–30. [CrossRef]
  • [28] Sousa J, Alves G, Fortuna A, Falcão A. Analytical Methods for Determination of New Fluoroquinolones in Biological Matrices and Pharmaceutical Formulations by Liquid Chromatography: A Review. Anal Bioanal Chem. 2012;403(1):93–129. [CrossRef]
  • [29] Roos RW, Lau-Cam CA. General Reversed-Phase High-Performance Liquid Chromatographic Method for the Separation of Drugs Using Triethylamine as a Competing Base. J Chromatogr A. 1986;370(C):403–418. [CrossRef]
  • [30] Thompson M, Ellison SLR, Wood R. Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis (IUPAC Technical Report). Pure Appl Chem. 2002;74(5):835–855.
  • [31] EMA. Validation of Analytical Procedures: Text and Methodology. London: European Medicines Agency; 1995.
  • [32] WHO. Guidelines on Validation – Appendix 4 Analytical Method Validation. Switzerland: World Health Organization; 2016.
  • [33] AOAC. Standard Format and Guidance for AOAC Standard Method Performance Requirement (SMPR) Documents. AOAC 2011:1–27.
  • [34] Rozet E, Ceccato A, Hubert C, Ziemons E, Oprean R, Rudaz S, Boulanger B, Hubert P. Analysis of Recent Pharmaceutical Regulatory Documents on Analytical Method Validation. J Chromatogr A. 2007;1158(1–2):111–125. [CrossRef]
  • [35] Gad SC, Levin S. High Performance Liquid Chromatography (HPLC) in the Pharmaceutical Analysis. 2010. [CrossRef]
  • [36] Amrutiya N, Madan M, Bajaj A. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Prednicarbate, Mupirocin and Ketoconazole in Topical Dosage Forms. J Anal Chem. 2010;65(11):1148–1154. [CrossRef]
  • [37] Avdeef A. Solubility of Sparingly-Soluble Ionizable Drugs. Adv Drug Deliv Rev. 2007;59(7):568–590. [CrossRef]
  • [38] Basheer L, Schultz K, Fichman M, Kerem Z. Use of in Vitro and Predictive in Silico Models to Study the Inhibition of Cytochrome P4503A by Stilbenes. PLoS One. 2015;10(10):1–17. [CrossRef]
  • [39] Baka E, Comer JEA, Takács-Novák K. Study of Equilibrium Solubility Measurement by Saturation Shake-Flask Method Using Hydrochlorothiazide as Model Compound. J Pharm Biomed Anal. 2008;46(2):335–341. [CrossRef]
  • [40] PubChem. Ketoconazole. https://pubchem.ncbi.nlm.nih.gov/compound/Ketoconazole (accessed on 23 May 2022)
Toplam 40 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Eczacılıkta Analitik Kimya
Bölüm Articles
Yazarlar

Viviane Annisa

Teuku Nanda Syaifullah Sulaiman

Akhmad Kharis Nugroho

Agung Endro Nugroho

Yayımlanma Tarihi 28 Haziran 2025
Yayımlandığı Sayı Yıl 2022 Cilt: 26 Sayı: 6

Kaynak Göster

APA Annisa, V., Sulaiman, T. N. S., Nugroho, A. K., Nugroho, A. E. (2025). Validation of RP-HPLC method for determination of pHdependent solubility of ketoconazole in phosphate buffer pH 6.8. Journal of Research in Pharmacy, 26(6), 1694-1702. https://doi.org/10.29228/jrp.260
AMA Annisa V, Sulaiman TNS, Nugroho AK, Nugroho AE. Validation of RP-HPLC method for determination of pHdependent solubility of ketoconazole in phosphate buffer pH 6.8. J. Res. Pharm. Haziran 2025;26(6):1694-1702. doi:10.29228/jrp.260
Chicago Annisa, Viviane, Teuku Nanda Syaifullah Sulaiman, Akhmad Kharis Nugroho, ve Agung Endro Nugroho. “Validation of RP-HPLC Method for Determination of PHdependent Solubility of Ketoconazole in Phosphate Buffer PH 6.8”. Journal of Research in Pharmacy 26, sy. 6 (Haziran 2025): 1694-1702. https://doi.org/10.29228/jrp.260.
EndNote Annisa V, Sulaiman TNS, Nugroho AK, Nugroho AE (01 Haziran 2025) Validation of RP-HPLC method for determination of pHdependent solubility of ketoconazole in phosphate buffer pH 6.8. Journal of Research in Pharmacy 26 6 1694–1702.
IEEE V. Annisa, T. N. S. Sulaiman, A. K. Nugroho, ve A. E. Nugroho, “Validation of RP-HPLC method for determination of pHdependent solubility of ketoconazole in phosphate buffer pH 6.8”, J. Res. Pharm., c. 26, sy. 6, ss. 1694–1702, 2025, doi: 10.29228/jrp.260.
ISNAD Annisa, Viviane vd. “Validation of RP-HPLC Method for Determination of PHdependent Solubility of Ketoconazole in Phosphate Buffer PH 6.8”. Journal of Research in Pharmacy 26/6 (Haziran 2025), 1694-1702. https://doi.org/10.29228/jrp.260.
JAMA Annisa V, Sulaiman TNS, Nugroho AK, Nugroho AE. Validation of RP-HPLC method for determination of pHdependent solubility of ketoconazole in phosphate buffer pH 6.8. J. Res. Pharm. 2025;26:1694–1702.
MLA Annisa, Viviane vd. “Validation of RP-HPLC Method for Determination of PHdependent Solubility of Ketoconazole in Phosphate Buffer PH 6.8”. Journal of Research in Pharmacy, c. 26, sy. 6, 2025, ss. 1694-02, doi:10.29228/jrp.260.
Vancouver Annisa V, Sulaiman TNS, Nugroho AK, Nugroho AE. Validation of RP-HPLC method for determination of pHdependent solubility of ketoconazole in phosphate buffer pH 6.8. J. Res. Pharm. 2025;26(6):1694-702.

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