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Simultaneous HPLC Determination of Lidocaine Hydrochloride and Hexachlorophene in a Suppository Product Cece Furwanti; Kusuma Hendrajaya; Gunawan Indrayanto
MPI (Media Pharmaceutica Indonesiana) Vol. 3 No. 1 (2020): JUNE
Publisher : Fakultas Farmasi, Universitas Surabaya

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24123/mpi.v3i1.2455

Abstract

Antihemoroid® suppository has been produced commercially by PT. Kimia Farma, Indonesia. For QC purposes, a separated densitometric method for analysis of its active ingredients, lidocaine hydrochloride and hexachlorophene, was applied. The objective of this study was obtaining more efficient analysis method of LH and HC, therefore an HPLC procedure has been developed for the determination of both compounds simultaneously. AYMC-Triart C18 column was used with a gradient mobile phase consisting of acetonitrile and phosphate buffer 0.05 M (pH 6.0). Quantitative evaluation was performed at 220 nm. Method validation was performed according to the new methods of USP 41. Result showed that the HPLC method was simple, accurate, precise, and robust. The HPLC method can be applied in simultaneous determination of LH and HC in suppositories as a QC tool in the pharmaceutical industries.
NON PHENOLIC COMPOUNDS ISOLATED FROM THE LEAVES OF FERN Chingia sakayensis (Zeiller) Holtt Suyatno Suyatno; Noor Cholies Zaini; Gunawan Indrayanto; Motoo Tori
Indonesian Journal of Chemistry Vol 6, No 1 (2006)
Publisher : Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (171.909 KB) | DOI: 10.22146/ijc.21779

Abstract

Two non phenolic compounds namely a wax ester hexacosyl hexadecanoic and   a steroid -sitosterol were isolated from the n-hexane extract of the fern Chingia sakayensis (Zeiller) Holtt's leaves. Their structures were elucidated on the basis of the spectrometric evidences  (UV, IR, 1H-NMR, 13C-NMR, EIMS and HR-CIMS).
Sterol and Triterpene Profiles of the Callus Culture of Solanum mammosum Juliana, Silvy; Suciati,; Indrayanto, Gunawan
Makara Journal of Science Vol. 23, No. 2
Publisher : UI Scholars Hub

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Abstract

This study aimed to compare the sterol and triterpene profiles of two types of Solanum mammosum callus cultures , i.e., compact globular structure (CGS) and normal fine (F) calluses. The CGS callus resulted from the differentiation of the F calus culture after many years of subculturing. The growth rate, microscopic characteristics, and morphologies of the two callus types were determined and compared. Sterols and triterpenes were identified through thin-layer chromatog-raphy, gas chromatography-flame ionization detection, and gas chromatography–mass spectrometry analyses. The growth rate of the CGS callus was lower than that of the F callus. Microscopic identification revealed that thick, lignincontaining cell walls formed in the CGS callus but not in the F callus. The chromatographic analysis suggested that the CGS and F callus cultures had different sterol and triterpenoid profiles. The sterols and triterpenes produced by the CGC culture were more diverse than those produced by the F callus culture
Identification of Massoia Lactone and its Hydroxy-derivative from Kabatiella caulivora, an Endophyte of the Terrestrial Plant Alyxia reinwardtii Laili, Izzatul; Gunarso, Sri; Wathan, Nashrul; Sugijanto, Noor Erma; Indrayanto, Gunawan
Makara Journal of Science Vol. 21, No. 4
Publisher : UI Scholars Hub

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Abstract

Massoia lactone (1) and its derivative, 3,5-dihydroxydecanoic acid-d-lactone (2), were identified from an ethyl acetate extract of the endophytic fungus Kabatiella caulivora, isolated from its host Alyxia reinwardtii. The compounds were identified by GC-MS. To the best of our knowledge, this is the first report of the identification of massoia lactone and its derivative from the endophytic K. caulivora fungus.
Identification of 4-4’-(1-methylethylidene)-bisphenol from an Endophytic Fungus Cladosporium oxysporum derived from Aglaia odorata Armila Fatma Setyaningrum; Risma Pratiwi; Suciati Suciati; Noor Erma Nasution Sugijanto; Gunawan Indrayanto
ALCHEMY Jurnal Penelitian Kimia Vol 14, No 2 (2018): September
Publisher : UNIVERSITAS SEBELAS MARET (UNS)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.20961/alchemy.14.2.12974.193-201

Abstract

Endophytic fungi has an economic potential as raw material for biologically active compounds. Cladosporium oxysporum is one of the endophytic fungi isolated from Indonesian medicinal plant Aglaia odorata Lour (Local name: Pacarcina). This planth has been used for fever, cough, diarrhea, inflammation and injury. In our previous study, the ethyl acetate extract and several fractions of the extract of C. oxysporum showed antimicrobial activity against Candida albicans, Escherichia coli, and Staphylococcus aureus. The objective of the currents study is to investigate the chemical constituent of the active fraction. Purification of the metabolite was achieved by using column chromatography followed by preparative thin layer chromatography. Identification of the metabolite was conducted by using TLC densitometry, GC-FID and GC-MS. Compound 1 was isolated from fraction 12. The purity of this compound was determined by 2D-TLC and GC-FID. The UV-Vis profile of compound 1 indicates a phenolic compound. Further analysis by using GC-MS shows one peak at a retention time (Rt) of 23.80 minutes, predicted as 4-4’-(1-methylethylidene)-bisphenol. The chemical constituent of the sub fraction 12.2.7 (fraction a) is identified as 4-4’-(1-methylethylidene)-bisphenol.
Application of Accuracy and Precision Evaluations Based on the Current United States and Indonesian Pharmacopoeias: A Critical Review Indrayanto, Gunawan
Makara Journal of Science Vol. 26, No. 4
Publisher : UI Scholars Hub

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Abstract

New methods for the evaluation of accuracy and precision are mentioned in the latest edition of the United States Pharmacopoeia (USP), whereas other validation parameters, that is, selectivity, linearity, range, and robustness, remained relatively unchanged. In obtaining reliable data from any chemical/pharmaceutical analysis, the analytical procedure must be validated or verified in accordance with the latest edition of the pharmacopoeia. Some review articles on the general validation methods have been published by the author. This present review will focus on the implementation and discussion of the accuracy and precision evaluation based on the current USP and Indonesian pharmacopoeia. Some examples of the calculation of several accuracy and precision method of determinations are also discussed.
Isolation of Pandangolide 1 from Cladosporium oxysporum, An Endophyte of the Terrestrial Plant Alyxia reinwardtii Hartanti, Dwi; Purwanti, Diah Intan; Putro, Herdayanto Sulistyo; Rateb, Mostafa Ezzat; Wongso, Suwidji; Sugijanto, Noor Erma; Ebel, Rainer; Indrayanto, Gunawan
Makara Journal of Science Vol. 18, No. 4
Publisher : UI Scholars Hub

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Abstract

that the 2011 IOD was a weak and short-lived event. It developed in July, peaked in September, decayed in October and
Analysis of Trends in Cosmetics Supervision Cases in Indonesia in 2021-2024 Kashuri, Mohamad; Ikrar, Taruna; Indrayanto, Gunawan
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 2 (2025): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i2.235

Abstract

This study offers a comprehensive analysis of cosmetic product regulation in Indonesia from 2021 to 2024, examining enforcement trends, patterns of regulatory non-compliance, and the evolving oversight role of the Indonesian Food and Drug Authority (BPOM). Data were obtained from BPOM’s annual inspection and enforcement reports and analyzed descriptively to identify changes in regulatory compliance over time. The results reveal that the majority of violations originated from Small and Medium-Sized Enterprises (SMEs), accounting for 1–2% of total cases, while larger industries reported slightly higher rates (2.7–6.9%). A significant 165% surge in products without distribution permits was recorded from 2021 to 2022, followed by substantial reductions in 2023 (85%) and 2024 (32%). Adherence to Good Cosmetic Manufacturing Practices (GCMP) showed a consistent improvement from 2022 onwards. Violations involving labeling, advertising, and product claims also declined, though more than 1,500 cases are still reported annually. Public education campaigns have played a crucial role in enhancing consumer awareness and minimizing exposure to unsafe products. Enforcement data further demonstrate a reduction in formal sanctions and warnings, reflecting BPOM’s strategic pivot toward a more preventive and facilitative regulatory approach. Looking ahead, BPOM needs to strengthen industry compliance by expanding its technical assistance initiatives through both direct consultations and digital platforms, supporting a more risk-based and innovation-friendly regulatory environment.